Drilling into “Quality by Design” Approach for Analytical Methods

References

• Stagner, W. C.; Haware, R. V. QbD Innovation through Advances in PAT, Data Analysis Methodologies, and Material Characterization. AAPS PharmSciTech 2019, 20, 295. DOI: 10.1208/s12249-019-1506-9.
   PubMed Web of Science ®Google Scholar
• FDA. GMP’s for the 21st Century. Department of Health and Human Services: Silver Spring, MD, 2004, pp 1–32.
   Google Scholar
• FDA. Guidance for Industry, PAT-A Framework for Innovative Pharmaceutical Development. Manufacturing and Quality Assurance: Silver Spring, MD, 2004.
   Google Scholar
• Juran, J. M. Juran on Quality by Design: The New Steps for Planning Quality into Goods and Services, 1st ed.; Free Press: New York, 1992.
   Google Scholar
• Bastogne, T.; Caputo, F.; Prina-Mello, A.; Borgos, S.; Barberi-Heyob, M. A State of the Art in Analytical Quality-by-Design and Perspectives in Characterization of Nano-Enabled Medicinal Products. J. Pharm. Biomed. Anal. 2022, 219, 114911. DOI: 10.1016/j.jpba.2022.114911.
   PubMed Web of Science ®Google Scholar
• Vogt, F. G.; Kord, A. S. Development of Quality-By-Design Analytical Methods. J. Pharm. Sci. 2011, 100, 797–812. DOI: 10.1002/jps.22325.
   PubMed Web of Science ®Google Scholar
• Mahapatra, A.; Meyyanathan, S. N. Analytical Quality by Design – A Review. IRJPS 2020, 7, 2132–2140. DOI: 10.21276/irjps.2020.7.2.4.
   Google Scholar
• Peraman, R.; Bhadraya, K.; Reddy, Y. P. Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics. Int. J. Anal. Chem. 2015, 2015, 868727. DOI: 10.1155/2015/868727.
   PubMed Web of Science ®Google Scholar
• Pharmaceutical Development – ICH Q8(R2). European Medicines Agency, 2009.
   Google Scholar
• Quality Risk Management ICH (Q9). European Medicines Agency, 2014.
   Google Scholar
• Pharmaceutical Quality System ICH (Q10). European Medicines Agency, 2015.
   Google Scholar
• Development and Manufacture of Drug Substances – ICH (Q11). European Medicines Agency, 2012.
   Google Scholar
• Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management – ICH (Q12). European Medicines Agency, 2020.
   Google Scholar
• Continuous Manufacturing of Drug Substances and Drug Products – ICH (Q13). European Medicines Agency, 2021.
   Google Scholar
• Sivaraman, A.; Banga, A. Quality by Design Approaches for Topical Dermatological Dosage Forms. RRTD 2015, 4, 9–21. DOI: 10.2147/RRTD.S82739.
   Google Scholar
• Analytical Procedure Development – ICH (Q14). 2022.
   Google Scholar
• Beg, S.; Hasnain, M. S.; Rahman, M.; Almalki, W. Handbook of Analytical Quality by Design, 1st ed.; Elsevier Ltd: Chennai, 2021. DOI: 10.1016/c2019-0-01419-7.
   Google Scholar
• Raman, N. V. V. S. S.; Mallu, U. R.; Bapatu, H. R. Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing. J. Chem. 2015, 2015, 1–8. DOI: 10.1155/2015/435129.
   Web of Science ®Google Scholar
• Grangeia, H. B.; Silva, C.; Simões, S. P.; Reis, M. S. Quality by Design in Pharmaceutical Manufacturing: A Systematic Review of Current Status, Challenges and Future Perspectives. Eur. J. Pharm. Biopharm. 2020, 147, 19–37. DOI: 10.1016/j.ejpb.2019.12.007.
   PubMed Web of Science ®Google Scholar
• Zhang, L.; Mao, S. Application of Quality by Design in the Current Drug Development. Asian J. Pharm. Sci. 2017, 12, 1–8. DOI: 10.1016/j.ajps.2016.07.006.
   PubMed Web of Science ®Google Scholar
• Sahu, P. K.; Ramisetti, N. R.; Cecchi, T.; Swain, S.; Patro, C. S.; Panda, J. An Overview of Experimental Designs in HPLC Method Development and Validation. J. Pharm. Biomed. Anal. 2018, 147, 590–611. DOI: 10.1016/j.jpba.2017.05.006.
   PubMed Web of Science ®Google Scholar
• Phadke, R.; Gosar, A.; Mali, R.; Patil, D. A Review on Quality by Design Approaches to Analytical Method Development. Indo Am. J. Pharm. Res. 2019, 9, 3044–3055.
   Google Scholar
• Sangshetti, J. N.; Deshpande, M.; Zaheer, Z.; Shinde, D. B.; Arote, R. Quality by Design Approach: Regulatory Need. Arab. J. Chem. 2017, 10, S3412–S3425. DOI: 10.1016/j.arabjc.2014.01.025.
   Web of Science ®Google Scholar
• Deidda, R.; Orlandini, S.; Hubert, P.; Hubert, C. Risk-Based Approach for Method Development in Pharmaceutical Quality Control Context: A Critical Review. J. Pharm. Biomed. Anal. 2018, 161, 110–121. DOI: 10.1016/j.jpba.2018.07.050.
   PubMed Web of Science ®Google Scholar
• Borman, P.; Campa, C.; Delpierre, G.; Hook, E.; Jackson, P.; Kelley, W.; Protz, M.; Vandeputte, O. Selection of Analytical Technology and Development of Analytical Procedures Using the Analytical Target Profile. Anal. Chem. 2022, 94, 559–570. DOI: 10.1021/acs.analchem.1c03854.
   PubMed Web of Science ®Google Scholar
• Sumit, K.; Shikha, T.; Deepika, T.; Ashish, B. A Quantitative Approach for Pharmaceutical Quality by Design Patterns. Inventi Rapid: Pharm Anal. Qual. Assur. 2012, 2012, 1–8.
   Google Scholar
• Bhutani, H.; Kurmi, M.; Singh, S.; Beg, S.; Singh, B. Quality by Design (QbD) in Analytical Sciences: An Overview. Pharma Times 2014, 46, 71–75.
   Google Scholar
• Walkiria, S.; Schlindwein, M. G. Pharmaceutical Quality by Design: A Practical Approach, 1st ed.; John Wiley & Sons: London, 2018.
   Google Scholar
• Fukuda, I. M.; Pinto, C. F. F.; Moreira, C. D. S.; Saviano, A. M.; Lourenço, F. R. Design of Experiments (DoE) Applied to Pharmaceutical and Analytical Quality by Design (QbD). Braz. J. Pharm. Sci. 2018, 54, 1–16. DOI: 10.1590/s2175-97902018000001006.
   Web of Science ®Google Scholar
• NIST/SEMATECH e-Handbook of Statistical Methods. www.itl.nist.gov/div898/handbook/ (accessed Jan 15, 2023). DOI: 10.18434/M32189.
   Google Scholar
• Takagaki, K.; Ito, T.; Arai, H.; Obata, Y.; Takayama, K.; Onuki, Y. The Usefulness of Definitive Screening Design for a Quality by Design Approach as Demonstrated by a Pharmaceutical Study of Orally Disintegrating Tablet. Chem. Pharm. Bull. 2019, 67, 1144–1151. DOI: 10.1248/cpb.c19-00553.
   PubMed Web of Science ®Google Scholar
• Montgomery, D. C. Design and Analysis of Experiments Eighth Edition, 8th ed.; Wiley;Arizona State University: Tempe, AZ, 2013; Vol. 2009.
   Google Scholar
• Jones, B.; Nachtsheim, C. J. Definitive Screening Designs with Added Two-Level Categorical Factors. J. Qual. Technol. 2013, 45, 121–129. DOI: 10.1080/00224065.2013.11917921.
   Web of Science ®Google Scholar
• Weese, M. L.; Ramsey, P. J.; Montgomery, D. C. Analysis of Definitive Screening Designs: Screening vs Prediction. Appl. Stochastic Models Bus. Ind. 2018, 34, 244–255. DOI: 10.1002/asmb.2297.
   Web of Science ®Google Scholar
• Ganorkar, S. B.; Shirkhedkar, A. A. Design of Experiments in Liquid Chromatography (HPLC) Analysis of Pharmaceuticals: Analytics, Applications, Implications and Future Prospects. Rev. Anal. Chem. 2017, 36, 1–43. DOI: 10.1515/revac-2016-0025.
   Web of Science ®Google Scholar
• Bezerra, M. A.; Santelli, R. E.; Oliveira, E. P.; Villar, L. S.; Escaleira, L. A. Response Surface Methodology (RSM) as a Tool for Optimization in Analytical Chemistry. Talanta 2008, 76, 965–977. DOI: 10.1016/j.talanta.2008.05.019.
   PubMed Web of Science ®Google Scholar
• Verseput, R. Digging into DOE. https://www.qualitydigest.com/june01/html/doe.html (accessed Nov 11, 2022).
   Google Scholar
• Develve. Central composite design. https://develve.net/Central Composite design.html (accessed Nov 11, 2022).
   Google Scholar
• Silveira, Z. d C. Análise Estatística e Otimização de Parâmetros de Projeto Em Componentes de Sistemas Mecânicos. 2003.
   Google Scholar
• Carr, B. T. Statistical Design of Experiments in the 21st Century and Implications for Consumer Product Testing. In Consumer-Driven Innovation in Food and Personal Care Products; Woodhead Publishing: Cambridge, 2010, pp 427–469. DOI: 10.1533/9781845699970.4.427.
   Google Scholar
• Czitrom, V. One-Factor-at-a-Time versus Designed Experiments. Am. Stat. 1999, 53, 126–131. DOI: 10.1080/00031305.1999.10474445.
   Web of Science ®Google Scholar
• Perez-Roman, I.; Kiekens, F.; Cordoba-Diaz, D.; Garcia-Rodriguez, J. J.; Cordoba-Diaz, M. Development of a Solid Formulation Containing a Microemulsion of a Novel Artemisia Extract with Nematocidal Activity for Oral Administration. Pharmaceutics 2020, 12, 873. DOI: 10.3390/pharmaceutics12090873.
   PubMed Web of Science ®Google Scholar
• Tome, T.; Žigart, N.; Časar, Z.; Obreza, A. Development and Optimization of Liquid Chromatography Analytical Methods by Using AQbD Principles: Overview and Recent Advances. Org. Process Res. Dev. 2019, 23, 1784–1802. DOI: 10.1021/acs.oprd.9b00238.
   Web of Science ®Google Scholar
• Jones, B.; Allen-Moyer, K.; Goos, P. A-Optimal versus D-Optimal Design of Screening Experiments. J. Qual. Technol. 2021, 53, 369–382. DOI: 10.1080/00224065.2020.1757391.
   Web of Science ®Google Scholar
• Validation of Analytical Procedures – ICH (Q2-R2). European Medicines Agency, 2022.
   Google Scholar
• Peraman, R.; Bhadraya, K.; Reddy, Y. P.; Reddy, C. S.; Lokesh, T. Analytical Quality by Design Approach in RP-HPLC Method Development for the Assay of Etofenamate in Dosage Forms. Indian J. Pharm. Sci. 2015, 77, 751–757. DOI: 10.4103/0250-474X.174971.
   PubMed Web of Science ®Google Scholar
• International Council Harmonization (ICH). Quality Risk Management Q9. 2023. https://database.ich.org/sites/default/files/ICH%20Q9R1_Step_4_Presentation_2023_0314.pdf.
   Google Scholar
• Borman, P.; Chatfield, M.; Nethercote, P.; Duncan Thompson, K. T. The Application of Quality by Design to Analytical Methods. Pharm. Technol. 2007, 31, 1–6.
   Google Scholar
• Weissman, S. A.; Anderson, N. G. Design of Experiments (DoE) and Process Optimization. A Review of Recent Publications. Org. Process Res. Dev. 2015, 19, 1605–1633. DOI: 10.1021/op500169m.
   Web of Science ®Google Scholar
• Jackson, P.; Borman, P.; Campa, C.; Chatfield, M.; Godfrey, M.; Hamilton, P.; Hoyer, W.; Norelli, F.; Orr, R.; Schofield, T. Using the Analytical Target Profile to Drive the Analytical Method Lifecycle. Anal. Chem. 2019, 91, 2577–2585. DOI: 10.1021/acs.analchem.8b04596.
   PubMed Web of Science ®Google Scholar
• Basso, J.; Mendes, M.; Cova, T. F. G. G.; Sousa, J. J.; Pais, A. A. C. C.; Vitorino, C. Analytical Quality by Design (AQbD) as a Multiaddressable Platform for Co-Encapsulating Drug Assays. Anal. Methods 2018, 10, 5659–5671. DOI: 10.1039/C8AY01695J.
   Web of Science ®Google Scholar
• Zacharis, C. K.; Vastardi, E. Application of Analytical Quality by Design Principles for the Determination of Alkyl P-Toluenesulfonates Impurities in Aprepitant by HPLC. Validation Using Total-Error Concept. J. Pharm. Biomed. Anal. 2018, 150, 152–161. DOI: 10.1016/j.jpba.2017.12.009.
   PubMed Web of Science ®Google Scholar
• Mitrović, M.; Protić, A.; Malenović, A.; Otašević, B.; Zečević, M. Analytical Quality by Design Development of an Ecologically Acceptable Enantioselective HPLC Method for Timolol Maleate Enantiomeric Purity Testing on Ovomucoid Chiral Stationary Phase. J. Pharm. Biomed. Anal. 2020, 180, 113034. DOI: 10.1016/j.jpba.2019.113034.
   PubMed Web of Science ®Google Scholar
• Gavin, P. F.; Olsen, B. A. A Quality by Design Approach to Impurity Method Development for Atomoxetine Hydrochloride (LY139603). J. Pharm. Biomed. Anal. 2008, 46, 431–441. DOI: 10.1016/j.jpba.2007.10.037.
   PubMed Web of Science ®Google Scholar
• Panda, S. S.; Ravi Kumar Bera, V. V.; Beg, S.; Mandal, O. Analytical Quality by Design (AQbD)-Oriented RP-UFLC Method for Quantification of Lansoprazole with Superior Method Robustness. J. Liq. Chromatogr. Relat. Technol. 2017, 40, 479–485. DOI: 10.1080/10826076.2017.1327442.
   Web of Science ®Google Scholar
• Gurrala, S.; Shivaraj S, S.; Cvs Subrahmanyam, S.; Anumolu, P. D.; Saraf, G. Analytical Quality by Design Assisted HPLC Method for Quantification of Canagliflozin/Metformin and Stability Studies. IJPER 2019, 53, s699–s709. DOI: 10.5530/ijper.53.4s.167.
   Google Scholar
• Terzić, J.; Popović, I.; Stajić, A.; Tumpa, A.; Jančić-Stojanovic, B. Application of Analytical Quality by Design Concept for Bilastine and Its Degradation Impurities Determination by Hydrophilic Interaction Liquid Chromatographic Method. J. Pharm. Biomed. Anal. 2016, 125, 385–393. DOI: 10.1016/j.jpba.2016.04.022.
   PubMed Web of Science ®Google Scholar
• Jain, A.; Beg, S.; Saini, S.; Sharma, T.; Katare, O. P.; Singh, B. Application of Chemometric Approach for QbD-Enabled Development and Validation of an RP-HPLC Method for Estimation of Methotrexate. J. Liq. Chromatogr. Relat. Technol. 2019, 42, 502–512. DOI: 10.1080/10826076.2019.1626742.
   Web of Science ®Google Scholar
• Awotwe-Otoo, D.; Agarabi, C.; Faustino, P. J.; Habib, M. J.; Lee, S.; Khan, M. A.; Shah, R. B. Application of Quality by Design Elements for the Development and Optimization of an Analytical Method for Protamine Sulfate. J. Pharm. Biomed. Anal. 2012, 62, 61–67. DOI: 10.1016/j.jpba.2012.01.002.
   PubMed Web of Science ®Google Scholar
• Dash, R. N.; Habibuddin, M.; Humaira, T.; Patel, A. A. Application of Quality by Design for the Optimization of an HPLC Method to Determine Ezetimibe in a Supersaturable Self-Nanoemulsifying Formulation. J. Liq. Chromatogr. Relat. Technol. 2015, 38, 874–885. DOI: 10.1080/10826076.2014.982867.
   Web of Science ®Google Scholar
• Wingert, N. R.; Ellwanger, J. B.; Bueno, L. M.; Gobetti, C.; Garcia, C. V.; Steppe, M.; Schapoval, E. E. S. Application of Quality by Design to Optimize a Stability-Indicating LC Method for the Determination of Ticagrelor and Its Impurities. Eur. J. Pharm. Sci. 2018, 118, 208–215. DOI: 10.1016/j.ejps.2018.03.029.
   PubMed Web of Science ®Google Scholar
• Dobričić, V.; Vukadinović, D.; Jančić-Stojanović, B.; Vladimirov, S.; Čudina, O. AQbD-Oriented Development of a New LC Method for Simultaneous Determination of Telmisartan and Its Impurities. Chromatographia 2017, 80, 1199–1209. DOI: 10.1007/s10337-017-3330-2.
   Web of Science ®Google Scholar
• Moreira, C. d S.; Lourenço, F. R. Development and Optimization of a Stability-Indicating Chromatographic Method for Verapamil Hydrochloride and Its Impurities in Tablets Using an Analytical Quality by Design (AQbD) Approach. Microchem. J. 2020, 154, 104610. DOI: 10.1016/j.microc.2020.104610.
   Web of Science ®Google Scholar
• Beg, S.; Sharma, G.; Katare, O. P.; Lohan, S.; Singh, B. Development and Validation of a Stability-Indicating Liquid Chromatographic Method for Estimating Olmesartan Medoxomil Using Quality by Design. J. Chromatogr. Sci. 2015, 53, 1048–1059. DOI: 10.4172/pharmaceutical-sciences.1000478.
   PubMed Web of Science ®Google Scholar
• Veerubhotla, K.; Walker, R. B. Development and Validation of a Stability-Indicating Rp-Hplc Method Using Quality by Design for Estimating Captopril. Pharm Sci. 2019, 81, 45–56. DOI: 10.4172/pharmaceutical-sciences.1000478.
   Web of Science ®Google Scholar
• Thummala, V. R. R.; Seshadri, R. K.; Mohan Tharlapu, S. S. J.; Ivaturi, M. R.; Nittala, S. R. Development and Validation of a UPLC Method by the QbD-Approach for the Estimation of Rabeprazole and Levosulpiride from Capsules. Sci. Pharm. 2014, 82, 307–326. DOI: 10.3797/scipharm.1310-17.
   PubMedGoogle Scholar
• Yabré, M.; Ferey, L.; Somé, T. I.; Sivadier, G.; Gaudin, K. Development of a Green HPLC Method for the Analysis of Artesunate and Amodiaquine Impurities Using Quality by Design. J. Pharm. Biomed. Anal. 2020, 190, 113507. DOI: 10.1016/j.jpba.2020.113507.
   PubMed Web of Science ®Google Scholar
• Patil, T. S.; Deshpande, A. S. Development of an Innovative Quality by Design (QbD) Based Stability-Indicating HPLC Method and Its Validation for Clofazimine from Its Bulk and Pharmaceutical Dosage Forms. Chromatographia 2019, 82, 579–590. DOI: 10.1007/s10337-018-3660-8.
   Web of Science ®Google Scholar
• Sumithra, M.; Ravichandiran, V. Green Approaches in Sample Preparation for the Estimation of Atenolol, Aspirin, Atorvastatin Calcium and Losartan Potassium in Bulk and Its Pharmaceutical Dosage Form Prior to Chromatographic Technique. Eurasian J. Anal. Chem. 2018, 13, 1–15. DOI: 10.29333/ejac/97223.
   Google Scholar
• R M, A.; A, I.; A E, E.-G.; G M, H. Implementing a Quality by Design Approach in Chromatographic Determination of Some Antidiabetic. SF J. Pharm. Anal. Chem. 2018, 1, 1–9.
   Google Scholar
• Patel, K. G.; Patel, A. T.; Shah, P. A.; Gandhi, T. R. Multivariate Optimization for Simultaneous Determination of Aspirin and Simvastatin by Reverse Phase Liquid Chromatographic Method Using AQbD Approach. Bull. Fac. Pharmacy, Cairo Univ. 2017, 55, 293–301. DOI: 10.1016/j.bfopcu.2017.08.003.
   Google Scholar
• Sylvester, B.; Tefas, L.; Vlase, L.; Tomuţă, I.; Porfire, A. A Quality by Design (QbD) Approach to the Development of a Gradient High-Performance Liquid Chromatography for the Simultaneous Assay of Curcuminoids and Doxorubicin from Long-Circulating Liposomes. J. Pharm. Biomed. Anal. 2018, 158, 395–404. DOI: 10.1016/j.jpba.2018.06.018.
   PubMed Web of Science ®Google Scholar
• Palakurthi, A. K.; Dongala, T.; Katakam, L. N. R. QbD Based Development of HPLC Method for Simultaneous Quantification of Telmisartan and Hydrochlorothiazide Impurities in Tablets Dosage Form. Pract. Lab. Med. 2020, 21, e00169. DOI: 10.1016/j.plabm.2020.e00169.
   PubMedGoogle Scholar
• Fanse, S.; Baghel, M.; Rajput, S. Uncovering Interaction by QbD in Optimization of Stability-Indicating HPLC Method for Simultaneous Estimation of Low-Dose Aspirin and Lansoprazole. Pharm. Sci. 2016, 78, 789–800. DOI: 10.4172/pharmaceutical-sciences.1000185.
   Web of Science ®Google Scholar
• Yeram, P.; Hamrapurkar, P. D.; Mukhedkar, P. Implementation of Quality by Design Approach to Develop and Validate Stability Indicating Assay Method for Simultaneous Estimation of Sofosbuvir and Ledipasvir in Bulk Drugs and Tablet Formulation. J. Phys. A Math. Theor. 2019, 10, 180–188.
   Google Scholar
• Bossunia, M. T. I.; Urmi, K. F.; Shaha, C. K. Quality-By-Design Approach to Stability Indicating RP-HPLC Analytical Method Development for Estimation of Canagliflozin API and Its Validation. PHME 2017, 8, 92–101. DOI: 10.5530/phm.2017.8.15.
   Google Scholar
• Dhal, C.; Ahmad, F. J.; Chauhan, A.; Jyothi, M.; Singh, R. M.; Saini, P. K.; Mathur, S. C.; Singh, G. N. Quality by Design Approach for Simultaneous Estimation of Doxycycline Hyclate and Curcumin by RP-HPLC Method. Indian J. Pharm. Sci. 2015, 77, 723–728. DOI: 10.4103/0250-474X.174992.
   PubMed Web of Science ®Google Scholar
• Nompari, L.; Orlandini, S.; Pasquini, B.; Campa, C.; Rovini, M.; Del Bubba, M.; Furlanetto, S. Quality by Design Approach in the Development of an Ultra-High-Performance Liquid Chromatography Method for Bexsero Meningococcal Group B Vaccine. Talanta 2018, 178, 552–562. DOI: 10.1016/j.talanta.2017.09.077.
   PubMed Web of Science ®Google Scholar
• C, V.; K Reddy, B.; S V, S. Quality-by-Design Approach to Selective Stability Indicating RP- HPLC Method Development and Validation for Estimation of Sofosbuvir in Bulk Drug. Int. J. Res. Pharm. Sci. 2018, 9, 298–308.
   Google Scholar
• Buralla, K. K.; Parthasarathy, V. Quality by Design Based Developed and Validation of RP-HPLC Method for Simultaneous Estimation of Pazopanib in Bulk and Pharmaceutical Dosage Forms. IJPI 2019, 9, 135–140. DOI: 10.5530/ijpi.2019.3.25.
   Google Scholar
• Bonde, S.; Bonde, C. G.; Prabhakar, B. Quality by Design Based Development and Validation of HPLC Method for Simultaneous Estimation of Paclitaxel and Vinorelbine Tartrate in Dual Drug Loaded Liposomes. Microchem. J. 2019, 149, 103982. DOI: 10.1016/j.microc.2019.103982.
   Web of Science ®Google Scholar
• Garg, N. K.; Sharma, G.; Singh, B.; Nirbhavane, P.; Katare, O. P. Quality by Design (QbD)-Based Development and Optimization of a Simple, Robust RP-HPLC Method for the Estimation of Methotrexate. J. Liq. Chromatogr. Relat. Technol. 2015, 38, 1629–1637. DOI: 10.1080/10826076.2015.1087409.
   Web of Science ®Google Scholar
• Kumar, P. A.; Thirupathi, D.; Kumar, Y. R.; Jayashree, A. Simultanious Determination of Related Organic Impurities of Ibuprofen and Paracetamol in Combination Solid Dosage Form by Rp-Hplc with Qbd Approach. Orient. J. Chem. 2017, 33, 1461–1468. DOI: 10.13005/ojc/330349.
   Google Scholar
• Sharma, G.; Thakur, K.; Raza, K.; Katare, O. P. Stability Kinetics of Fusidic Acid: Development and Validation of Stability Indicating Analytical Method by Employing Analytical Quality by Design Approach in Medicinal Product(S). J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2019, 1120, 113–124. DOI: 10.1016/j.jchromb.2019.05.001.
   PubMed Web of Science ®Google Scholar
• Shah, U.; Shah, K.; Patel, R. Stability-Indicating Analytical Method Development Using Quality by Design Approach for Simultaneous Estimation of Ezetimibe and Glimepiride. Pharm. Sci. 2019, 81, 273–281. DOI: 10.4172/pharmaceutical-sciences.1000508.
   Web of Science ®Google Scholar
• Ellwanger, J. B.; Wingert, N. R.; Volpato, N. M.; Garcia, C. V.; Schapoval, E. E. S.; Steppe, M. Analytical Quality by Design Approach for a Stability-Indicating Method to Determine Apixaban and Its Related Impurities. Chromatographia 2020, 83, 65–75. DOI: 10.1007/s10337-019-03815-9.
   Web of Science ®Google Scholar
• Gundala, A.; Bharathi, K.; Prasad, K. V. S. R. G. Analytical Quality by Design Approach in Rp-Hplc Method Development for the Assay of Pitavastatin in Tablet Dosage Form. Int. J. Pharm. Sci. Res. 2018, 9, 4992–5001. DOI: 10.13040/IJPSR.0975-8232.9(11).4992-01.
   Web of Science ®Google Scholar
• Zhang, X.; Hu, C. Application of Quality by Design Concept to Develop a Dual Gradient Elution Stability-Indicating Method for Cloxacillin Forced Degradation Studies Using Combined Mixture-Process Variable Models. J. Chromatogr. A 2017, 1514, 44–53. DOI: 10.1016/j.chroma.2017.07.062.
   PubMed Web of Science ®Google Scholar
• Milošević, N.; Vemić, A.; Čolović, J.; Kostić, N.; Malenović, A. Design of Experiments–Design Space Approach for Development of Chaotropic Chromatography Method for Determination of Trimetazidine Dihydrochloride and Two Impurities. Chromatographia 2017, 80, 585–592. DOI: 10.1007/s10337-017-3275-5.
   Web of Science ®Google Scholar
• Patel, M. N.; Kothari, C. S. Multivariate Approaches for Simultaneous Determination of Avanafil and Dapoxetine by UV Chemometrics and HPLC-QbD in Binary Mixtures and Pharmaceutical Product. J. AOAC Int. 2016, 99, 649–663. DOI: 10.5740/jaoacint.15-0259.
   Web of Science ®Google Scholar
• Otašević, B.; Šljivić, J.; Protić, A.; Maljurić, N.; Malenović, A.; Zečević, M. Comparison of AQbD and Grid Point Search Methodology in the Development of Micellar HPLC Method for the Analysis of Cilazapril and Hydrochlorothiazide Dosage Form Stability. Microchem. J. 2019, 145, 655–663. DOI: 10.1016/j.microc.2018.11.033.
   Web of Science ®Google Scholar
• Saroj, S.; Jairaj, V.; Rathod, R. Applying Green Analytical Chemistry for Development and Validation of RP-HPLC Stability Indicating Assay Method for Estimation of Fenoverine in Bulk and Dosage Form Using Quality by Design Approach. J. Liq. Chromatogr. Relat. Technol. 2017, 40, 340–352. DOI: 10.1080/10826076.2017.1304414.
   Web of Science ®Google Scholar
• SHAkYA, A. k. Development and Validation of a Stability-Indicating Liquid Chromatographic Method for Determination of Valsartan and Hydrochlorthiazide Using Quality by Design. Orient. J. Chem. 2016, 32, 777–788. DOI: 10.1093/chromsci/bmw127.
   Google Scholar
• Saha, C.; Gupta, N. V.; Chandan, R. S. Development and Validation of a UPLC-MS Method for Determination of Atazanavir Sulfate by the “Analytical Quality by Design” Approach. Acta Pharm. 2020, 70, 17–33. DOI: 10.2478/acph-2020-0008.
   PubMed Web of Science ®Google Scholar
• Du, J.; Chang, Y.; Zhang, X.; Hu, C. Development of a Method of Analysis for Profiling of the Impurities in Phenoxymethylpenicillin Potassium Based on the Analytical Quality by Design Concept Combined with the Degradation Mechanism of Penicillins. J. Pharm. Biomed. Anal. 2020, 186, 113309. DOI: 10.1016/j.jpba.2020.113309.
   PubMed Web of Science ®Google Scholar
• Reid, G. L.; Cheng, G.; Fortin, D. T.; Harwood, J. W.; Morgado, J. E.; Wang, J.; Xue, G. Reversed-Phase Liquid Chromatographic Method Development in an Analytical Quality by Design Framework. J. Liq. Chromatogr. Relat. Technol. 2013, 36, 2612–2638. DOI: 10.1080/10826076.2013.765457.
   Web of Science ®Google Scholar
• S. S.; Gawande, A. T.; Hemke, K.; R.; G.; M. J.; U. Development of Rp-Hplc Method for the Estimation of Acotiamide Hydrochloride Hydrate Using AQbD Approach. Int. J. Pharm. Sci. Res. 2020, 11, 4530–4539. DOI: 10.13040/IJPSR.0975-8232.11(9).4530-39.
   Web of Science ®Google Scholar
• Tumpa, A.; Stajić, A.; Jančić-Stojanović, B.; Medenica, M. Quality by Design in the Development of Hydrophilic Interaction Liquid Chromatography Method with Gradient Elution for the Analysis of Olanzapine. J. Pharm. Biomed. Anal. 2017, 134, 18–26. DOI: 10.1016/j.jpba.2016.11.010.
   PubMed Web of Science ®Google Scholar
• Habib, A. A.; Hammad, S. F.; Megahed, S. M.; Kamal, A. H. Innovative Quality by Design Approach for Development of Green Micellar HPLC Method for Simultaneous Determination of Atorvastatin and Amlodipine. Chromatographia 2020, 83, 1221–1231. DOI: 10.1007/s10337-020-03937-5.
   Web of Science ®Google Scholar
• Zakrajšek, J.; Stojić, V.; Bohanec, S.; Urleb, U. Quality by Design Based Optimization of a High Performance Liquid Chromatography Method for Assay Determination of Low Concentration Preservatives in Complex Nasal Formulations. Acta Chim. Slov. 2015, 62, 72–82. DOI: 10.17344/acsi.2014.718.
   PubMed Web of Science ®Google Scholar
• Yadav, N. K.; Raghuvanshi, A.; Sharma, G.; Beg, S.; Katare, O. P.; Nanda, S. QbD-Based Development and Validation of a Stability-Indicating HPLC Method for Estimating Ketoprofen in Bulk Drug and Proniosomal Vesicular System. J. Chromatogr. Sci. 2016, 54, 377–389. DOI: 10.1093/chromsci/bmv151.
   PubMed Web of Science ®Google Scholar
• Sandhu, P. S.; Beg, S.; Katare, O. P.; Singh, B. QbD-Driven Development and Validation of a HPLC Method for Estimation of Tamoxifen Citrate with Improved Performance. J. Chromatogr. Sci. 2016, 54, 1373–1384. DOI: 10.1093/chromsci/bmw090.
   PubMed Web of Science ®Google Scholar
• Jayagopal, B.; Murugesh, S. QbD-Mediated RP-UPLC Method Development Invoking an FMEA-Based Risk Assessment to Estimate Nintedanib Degradation Products and Their Pathways. Arab. J. Chem. 2020, 13, 7087–7103. DOI: 10.1016/j.arabjc.2020.07.014.
   Web of Science ®Google Scholar
• Alekya, P.; Varalakshmi, K. V.; Pawar, A. K. M. Quality by Design (QbD) Based Development of a Stability Indicating Rp- Hplc Method for Estimation of Cobicistat in Bulk. Int. J. Pharm. Sci. Res. 2018, 9, 2589–2594. DOI: 10.1128/AAC.03728-14.
   Web of Science ®Google Scholar
• Shah, K.; Parmar, V. Quality by Design Based Method Development for Simultaneous Estimation of Montelukast Sodium and Theophylline in Tablet Dosage Form. CPA 2019, 15, 612–623. DOI: 10.2174/1573412914666180827143700.
   Google Scholar
• Mokhtar, H. I.; Abdel-Salam, R. A.; Haddad, G. M. Development of a Fast High Performance Liquid Chromatographic Screening System for Eight Antidiabetic Drugs by an Improved Methodology of In-Silico Robustness Simulation. J. Chromatogr. A 2015, 1399, 32–44. DOI: 10.1016/j.chroma.2015.04.038.
   PubMed Web of Science ®Google Scholar
• Manranjan, V. C.; Yadav, D. S.; Jogia, H. A.; Chauhan, P. L. Design of Experiment (DOE) Utilization to Develop a Simple and Robust Reversed-Phase HPLC Technique for Related Substances’ Estimation of Omeprazole Formulations. Sci. Pharm. 2013, 81, 1043–1056. DOI: 10.3797/scipharm.1306-06.
   PubMedGoogle Scholar
• Patel, A.; Shah, B.; Patel, K.; Paul, A.; Desai, R. RP-HPLC Method Development and Validation Using Experimental Design Approach for Simultaneous Estimation of Thiocolchicoside and Dexketoprofen with Forced Degradation Studies. Int. J. Adv. Res. Rev. 2016, 1, 178–195.
   Google Scholar
• Kovács, B.; Boda, F.; Fülöp, I.; Székely-Szentmiklósi, I.; Kelemen, É. K.; Kovács-Deák, B.; Székely-Szentmiklósi, B. HPLC Method Development for Fampridine Using Analytical Quality by Design Approach. Acta Pharm. 2020, 70, 465–482. DOI: 10.2478/acph-2020-0036.
   PubMed Web of Science ®Google Scholar
• Suleman, S.; Vandercruyssen, K.; Wynendaele, E.; D'Hondt, M.; Bracke, N.; Duchateau, L.; Burvenich, C.; Peremans, K.; De Spiegeleer, B. A Rapid Stability-Indicating, Fused-Core HPLC Method for Simultaneous Determination of β-Artemether and Lumefantrine in anti-Malarial Fixed Dose Combination Products. Malar. J. 2013, 12, 145. DOI: 10.1186/1475-2875-12-145.
   PubMed Web of Science ®Google Scholar
• Dawud, E. R.; Shakya, A. K. HPLC-PDA Analysis of ACE-Inhibitors, Hydrochlorothiazide and Indapamide Utilizing Design of Experiments. Arab. J. Chem. 2019, 12, 718–728. DOI: 10.1016/j.arabjc.2014.10.052.
   Web of Science ®Google Scholar
• Baghel, M.; Rajput, S. J. Stress Degradation of Edaravone: Separation, Isolation and Characterization of Major Degradation Products. Biomed. Chromatogr. 2018, 32, 1–13. DOI: 10.1002/bmc.4146.
   Web of Science ®Google Scholar
• Kurmi, M.; Kumar, S.; Singh, B.; Singh, S. Implementation of Design of Experiments for Optimization of Forced Degradation Conditions and Development of a Stability-Indicating Method for Furosemide. J. Pharm. Biomed. Anal. 2014, 96, 135–143. DOI: 10.1016/j.jpba.2014.03.035.
   PubMed Web of Science ®Google Scholar
• Debrus, B.; Guillarme, D.; Rudaz, S. Improved Quality-by-Design Compliant Methodology for Method Development in Reversed-Phase Liquid Chromatography. J. Pharm. Biomed. Anal. 2013, 84, 215–223. DOI: 10.1016/j.jpba.2013.06.013.
   PubMed Web of Science ®Google Scholar
• Mittal, A.; Parmar, S.; Gilani, S. J.; Imam, S. S.; Taleuzzaman, M. Optimization and Validation for Simultaneous Estimation of Citicoline and Piracetam in Bulk and Tablet Formulations Using RP-HPLC Method: Analytical Quality by Design Approach. Asia. J. Res. Chem. 2017, 10, 198. DOI: 10.5958/0974-4150.2017.00034.7.
   Google Scholar
• Krishna, M. V.; Dash, R. N.; Jalachandra Reddy, B.; Venugopal, P.; Sandeep, P.; Madhavi, G. Quality by Design (QbD) Approach to Develop HPLC Method for Eberconazole Nitrate: Application Oxidative and Photolytic Degradation Kinetics. J. Saudi Chem. Soc. 2016, 20, S313–S322. DOI: 10.1016/j.jscs.2012.12.001.
   Web of Science ®Google Scholar
• Karmarkar, S.; Yang, X.; Garber, R.; Szajkovics, A.; Koberda, M. Quality by Design (QbD) Based Development and Validation of an HPLC Method for Amiodarone Hydrochloride and Its Impurities in the Drug Substance. J. Pharm. Biomed. Anal. 2014, 100, 167–174. DOI: 10.1016/j.jpba.2014.07.002.
   PubMed Web of Science ®Google Scholar
• Mukthinuthalapati, M. A.; Bukkapatnam, V.; Kallepalli, P. Simultaneous Determination of anti-Diabetic Drugs in Their Combined Dosage Forms Using HPLC: An Experimental Design Approach. J. Chromatogr. Sci. 2019, 57, 339–348. DOI: 10.1093/chromsci/bmz003.
   PubMed Web of Science ®Google Scholar
• Bardan, M. Y. H.; Shakya, A. K. Stability Indicating HPLC-PDA Determination of Febuxostat Utilizing Design of Experiments and Its Application to Formulation and Dissolution Studies. Indian J. Heterocycl. Chem. 2016, 26, 23–35.
   Web of Science ®Google Scholar
• Hariram, B.; Kumar, R. S.; Jaya Shree, A.; Rao, D. V.; Kalyanaraman, L.; Srinivas, K. Ultra-High Performance Method on Superficially Porous Stationary Phase for the Determination of Related Substances in Pitavastatin Calcium by HPLC. Chromatographia 2015, 78, 1017–1029. DOI: 10.1007/s10337-015-2922-y.
   Web of Science ®Google Scholar
• Basso, J.; Ramos, M. L.; Pais, A.; Vitorino, R.; Fortuna, A.; Vitorino, C. Expediting Disulfiram Assays through a Systematic Analytical Quality by Design Approach. Chemosensors 2021, 9, 172. DOI: 10.3390/chemosensors9070172.
   Web of Science ®Google Scholar
• Kannaiah, K. P.; Sugumaran, A. Environmental Benign AQbD Based Estimation of Ketoconazole and Beclomethasone by RP-HPLC and Multi-Analytical UV Spectrophotometric Method. Microchem. J. 2022, 172, 106968. DOI: 10.1016/j.microc.2021.106968.
   Web of Science ®Google Scholar
• Separovic, L.; Lourenço, F. R. Measurement Uncertainty Evaluation of an Analytical Procedure for Determination of Terbinafine Hydrochloride in Creams by HPLC and Optimization Strategies Using Analytical Quality by Design. Microchem. J. 2022, 178, 107386. DOI: 10.1016/j.microc.2022.107386.
   Web of Science ®Google Scholar
• Pasquini, B.; Orlandini, S.; Furlanetto, S.; Gotti, R.; Del Bubba, M.; Boscaro, F.; Bertaccini, B.; Douša, M.; Pieraccini, G. Quality by Design as a Risk-Based Strategy in Pharmaceutical Analysis: Development of a Liquid Chromatography-Tandem Mass Spectrometry Method for the Determination of Nintedanib and Its Impurities. J. Chromatogr. A 2020, 1611, 460615. DOI: 10.1016/j.chroma.2019.460615.
   PubMed Web of Science ®Google Scholar
• Radić, I.; Runje, M.; Babić, S. Development of an Analytical Method for the Determination of Pimavanserin and Its Impurities Applying Analytical Quality by Design Principles as a Risk-Based Strategy. J. Pharm. Biomed. Anal. 2021, 201, 114091. DOI: 10.1016/j.jpba.2021.114091.
   PubMed Web of Science ®Google Scholar
• Pasquini, B.; Gotti, R.; Villar-Navarro, M.; Douša, M.; Renai, L.; Del Bubba, M.; Orlandini, S.; Furlanetto, S. Analysis Analytical Quality by Design in the Development of a Solvent-Modified Micellar Electrokinetic Chromatography Method for the Determination of Sitagliptin and Its Related Compounds. J. Pharm. Biomed. Anal. 2021, 202, 114163. DOI: 10.1016/j.jpba.2021.114163.
   PubMed Web of Science ®Google Scholar
• Abreu, J. C.; Mahr, A. G.; Lucio, C. Stability-Indicating Method Development for Quantification of Bromopride, Its Impurities, and Degradation Products by Ultra-High Performance Liquid Chromatography Applying Analytical Quality by Design Principles. J. Pharm. Biomed. Anal. 2021, 205, 114306. DOI: 10.1016/j.jpba.2021.114306.
   PubMed Web of Science ®Google Scholar
• Teng, J.; Zhu, C.; Lyu, J.; Pan, L.; Zhang, M.; Zhang, F.; Wu, H. Analytical Lifecycle Management (ALM) and Analytical Quality by Design (AQbD) for Analytical Procedure Development of Related Substances in Tenofovir Alafenamide Fumarate Tablets. J. Pharm. Biomed. Anal. 2022, 207, 114417. DOI: 10.1016/j.jpba.2021.114417.
   PubMed Web of Science ®Google Scholar
• Tzanavaras, P. D.; Chatzitaki, A.; Karavasili, C.; Sarigiannis, Y.; Fatouros, D. G.; Zacharis, C. K. Analytical Quality-by-Design Optimization of UHPLC Method for the Analysis of Octreotide Release from a Peptide-Based Hydrogel In-Vitro. J. Pharm. Biomed. Anal. 2022, 214, 114699. DOI: 10.1016/j.jpba.2022.114699.
   PubMed Web of Science ®Google Scholar
• Kannaiah, K. P.; Sugumaran, A.; Chanduluru, H. K. Simultaneous Estimation of Crotamiton and Hydrocortisone by RP-UPLC Using Green Analytical Principles Embedded Analytical Quality by Design (AQbD) Method. Microchem. J. 2023, 184, 108166. DOI: 10.1016/j.microc.2022.108166.
   Web of Science ®Google Scholar
• Kokilambigai, K. S.; Lakshmi, K. S. Analytical Quality by Design Assisted RP-HPLC Method for Quantifying Atorvastatin with Green Analytical Chemistry Perspective. J. Chromatogr. Open 2022, 2, 100052. DOI: 10.1016/j.jcoa.2022.100052.
   Google Scholar
• Muchakayala, S. K.; Katari, N. K.; Saripella, K. K.; Schaaf, H.; Marisetti, V. M.; Ettaboina, S. K.; Rekulapally, V. K. Implementation of Analytical Quality by Design and Green Chemistry Principles to Develop an Ultra-High Performance Liquid Chromatography Method for the Determination of Fluocinolone Acetonide Impurities from Its Drug Substance and Topical Oil Formulations. J. Chromatogr. A 2022, 1679, 463380. DOI: 10.1016/j.chroma.2022.463380.
   PubMed Web of Science ®Google Scholar
• Ntontis, S.; Tsanaktsidou, E.; Tzanavaras, P. D.; Kachrimanis, K.; Markopoulou, C. K.; Zacharis, C. K. Analytical Quality by Design Approach for the Determination of Imidazole in Sildenafil API and Its Formulations Using Zwitterionic HILIC Stationary Phase. J. Pharm. Biomed. Anal. 2023, 224, 115186. DOI: 10.1016/j.jpba.2022.115186.
   PubMed Web of Science ®Google Scholar
• Abdel-Moety, E. M.; Rezk, M. R.; Wadie, M.; Tantawy, M. A. A Combined Approach of Green Chemistry and Quality-by-Design for Sustainable and Robust Analysis of Two Newly Introduced Pharmaceutical Formulations Treating Benign Prostate Hyperplasia. Microchem. J. 2021, 160, 105711. DOI: 10.1016/j.microc.2020.105711.
   Web of Science ®Google Scholar
• Rocha, A. L.; Lourenço, F. R. Talanta Development and Optimization of a LC-MS/MS Compatible Method for Quantification of Losartan, Hydrochlorothiazide and Their Impurities Using AQbD Approach and Measurement Uncertainty Evaluation. Talanta 2023, 259, 124481. DOI: 10.1016/j.talanta.2023.124481.
   PubMed Web of Science ®Google Scholar
• Salwa, Kumar, L. Quality-by-Design Driven Analytical Method (AQbD) Development and Validation of HPLC–UV Technique to Quantify Rivastigmine Hydrogen Tartrate in Lipidic Nanocarriers: Forced Degradation, and Assessment of Drug Content and In Vitro Release Studies. Microchem. J., 2023, 193,108944. DOI: 10.1016/j.microc.2023.108944.
   Web of Science ®Google Scholar
• Nakka, S.; Katari, N. K.; Muchakayala, S. K.; Jonnalagadda, S. B.; Babu, S. Isolation, Identification, Structural Elucidation, and Toxicity Prediction Using (Q)-SAR Models of Two Degradants: AQbD-Driven LC Method to Determine the Roxadustat Impurities. Talanta Open 2023, 7, 100221. DOI: 10.1016/j.talo.2023.100221.
   Google Scholar
• Panda, S. S.; Afzal, O.; Altamimi, A. S. A.; Beg, S. Simultaneous Estimation of Neratinib and Naringenin from Pharmaceuticals Using a Stability-Indicating Liquid Chromatographic Method: Application to Analytical Quality by Design Concept and Multi-Tool Method Greenness Assessment. Microchem. J. 2023, 191, 108848. DOI: 10.1016/j.microc.2023.108848.
   Web of Science ®Google Scholar
• da Silva, F. A.; Lourenço, F. R.; Calixto, L. A. Development and Optimization of Stability-Indicating Method of Ethinylestradiol, Levonorgestrel, and Their Main Impurities Using Quality by Design Approach. J. Pharm. Biomed. Anal. 2023, 225, 115208. DOI: 10.1016/j.jpba.2022.115208.
   PubMed Web of Science ®Google Scholar
• Kumbhar, P.; Waghmare, P.; Nadaf, S.; Manjappa, A.; Shah, R.; Disouza, J. QbD and Six Sigma Quality Approach for Chromatographic Estimation of Repurposed Simvastatin from Nanostructured Lipid Carriers. Microchem. J. 2023, 185, 108310. DOI: 10.1016/j.microc.2022.108310.
   Web of Science ®Google Scholar
• Santos, N. O. d.; Wingert, N. R.; Steppe, M. Quality by Design Approach for Enantiomeric Evaluation by RP-HPLC Method of Rivaroxaban and Its Chiral Impurity. Microchem. J. 2023, 192, 108911. DOI: 10.1016/j.microc.2023.108911.
   Web of Science ®Google Scholar
• Ihssane, B.; Charrouf, M.; Abourriche, A.; Abboud, Y.; Bouabidi, A.; Bennamara, A.; Saffaj, T. Optimization and Validation of a New High-Performance Liquid Chromatographic Method for Analysis of Acetazolamide in Tablets Using Box-Behnken Statistical Experiment Design. Acta Chromatogr. 2011, 23, 41–57. DOI: 10.1556/AChrom.23.2011.1.2.
   Web of Science ®Google Scholar
• Nadella, N. P.; Ratnakaram, V. N.; Srinivasu, N. Development and Validation of UPLC Method for Simultaneous Quantification of Carvedilol and Ivabradine in the Presence of Degradation Products Using DoE Concept. J. Liq. Chromatogr. Relat. Technol. 2018, 41, 143–153. DOI: 10.1080/10826076.2018.1427595.
   Web of Science ®Google Scholar
• Choiri, S.; Ainurofiq, A.; Ratri, R.; Zulmi, M. U. Analytical Method Development of Nifedipine and Its Degradants Binary Mixture Using High Performance Liquid Chromatography through a Quality by Design Approach. IOP Conf. Ser.: Mater. Sci. Eng. 2018, 333, 012064. DOI: 10.1088/1757-899X/333/1/012064.
   Google Scholar
• Khan, A.; Imam, S. S.; Aqil, M.; Sultana, Y.; Ali, A.; Khan, K. Design of Experiment Based Validated Stability Indicating RP-HPLC Method of Temozolomide in Bulk and Pharmaceutical Dosage Forms. Beni-Suef Univ. J. Basic Appl. Sci. 2016, 5, 402–408. DOI: 10.1016/j.bjbas.2015.11.011.
   Google Scholar
• Ashu, M.; Shika, P.; Sadaf Jamal, G.; Syed Sarim, I.; Mohamad, T. Design of Experiment Based Optimized RP-HPLC Method for Simultaneous Estimation of Amlodipine and Valsartan in Bulk and Tablet Formulations. Austin J. Anal. Pharm. Chem. 2015, 2, 1–6. DOI: 10.5958/0974-4150.2017.00034.7.
   Google Scholar
• Shah, P.; Pandya, T.; Gohel, M.; Thakkar, V. Development and Validation of HPLC Method for Simultaneous Estimation of Rifampicin and Ofloxacin Using Experimental Design. J. Taibah Univ. Sci. 2019, 13, 146–154. DOI: 10.1080/16583655.2018.1548748.
   Web of Science ®Google Scholar
• EL-Fatatry, H. M.; Habib, A.; Hammad, S. F.; B, A. I. Development and Validation of Quality by Design Optimized Reversed Phase HPLC Method for Simultaneous Estimation of Telmisartan and Amlodipine. Int. J. Biol. Pharm. Res. 2013, 10, 697–701.
   Google Scholar
• Ramani, V. D.; Jani, G. K.; Sen, A. K.; Sailor, G. U.; Sutariya, V. B. Development and Validation of RP-HPLC Method for Pitavastatin Calcium in Bulk and Formulation Using Experimental Design. J. Appl. Pharm. Sci. 2019, 9, 075–083. DOI: 10.7324/JAPS.2019.91010.
   Google Scholar
• Ganorkar, S. B.; Dhumal, D. M.; Shirkhedkar, A. A. Development and Validation of Simple RP-HPLC-PDA Analytical Protocol for Zileuton Assisted with Design of Experiments for Robustness Determination. Arab. J. Chem. 2017, 10, 273–282. DOI: 10.1016/j.arabjc.2014.03.009.
   Web of Science ®Google Scholar
• Murthy, M. V.; Krishnaiah, C.; Srinivas, K.; Rao, K. S.; Kumar, N. R.; Mukkanti, K. Development and Validation of RP-UPLC Method for the Determination of Darifenacin Hydrobromide, Its Related Compounds and Its Degradation Products Using Design of Experiments. J. Pharm. Biomed. Anal. 2013, 72, 40–50. DOI: 10.1016/j.jpba.2012.09.013.
   PubMed Web of Science ®Google Scholar
• Gopireddy, R. R.; Maruthapillai, A.; Devikala, S.; Tamilselvi, M.; Arockia Selvi, J.; Mahapatra, S. DoE Approach: A Validated Stability Indicating RP-HPLC Method Development for the Separation of Diasteromeric Analogs and Process Impurities of Carfilzomib. Mater. Today Proc. 2019, 14, 514–531. DOI: 10.1016/j.matpr.2019.04.174.
   Google Scholar
• Kumar, L.; Sreenivasa Reddy, M.; Managuli, R. S.; Pai K, G. Full Factorial Design for Optimization, Development and Validation of HPLC Method to Determine Valsartan in Nanoparticles. Saudi Pharm. J. 2015, 23, 549–555. DOI: 10.1016/j.jsps.2015.02.001.
   PubMed Web of Science ®Google Scholar
• Srinubabu, G.; Raju, C. A. I.; Sarath, N.; Kumar, P. K.; Rao, J. V. L. N. S. Development and Validation of a HPLC Method for the Determination of Voriconazole in Pharmaceutical Formulation Using an Experimental Design. Talanta 2007, 71, 1424–1429. DOI: 10.1016/j.talanta.2006.04.042.
   PubMed Web of Science ®Google Scholar
• Iuliani, P.; Carlucci, G.; Marrone, A. Investigation of the HPLC Response of NSAIDs by Fractional Experimental Design and Multivariate Regression Analysis. Response Optimization and New Retention Parameters. J. Pharm. Biomed. Anal. 2010, 51, 46–55. DOI: 10.1016/j.jpba.2009.08.001.
   PubMed Web of Science ®Google Scholar
• Singh, V. D.; Daharwal, S. J. Optimization of RP-HPLC Method for Simultaneous Estimation of Lamivudine and Raltegravir in Binary Mixture by Using Design of Experiment. Eurasian J. Anal. Chem. 2016, 12, 179–195. DOI: 10.12973/ejac.2017.00162a.
   Google Scholar
• Dinç-Zor, Ş.; Dönmez, Ö. A.; Aşçı, B.; Pingo, E. Chemometric Optimization of an HPLC Method for the Simultaneous Analysis of a Multi Component Drug Product by the Help of Central Composite Design. Microchem. J. 2020, 152, 104322. DOI: 10.1016/j.microc.2019.104322.
   Web of Science ®Google Scholar
• Kavitapu, D.; Maruthapillai, A.; Mahapatra, S.; Arockia Selvi, J. New Stability Indicating RP-HPLC Method for the Determination of Abiraterone Acetate, Its Related Substances and Degradation Products in Bulk and Dosage Form. Mater. Today Proc. 2021, 34, 469–478. DOI: 10.1016/j.matpr.2020.02.665.
   Google Scholar
• Mbinze, J. K.; Dispas, A.; Lebrun, P.; Mbay, J. M. T.; Habyalimana, V.; Kalenda, N.; Rozet, E.; Hubert, P.; Marini, R. D. Application of an Innovative Design Space Optimization Strategy to the Development of LC Methods for the Simultaneous Screening of Antibiotics to Combat Poor Quality Medicines. J. Pharm. Biomed. Anal. 2013, 85, 83–92. DOI: 10.1016/j.jpba.2013.06.036.
   PubMed Web of Science ®Google Scholar
• Khamanga, S. M.; Walker, R. B. The Use of Experimental Design in the Development of an HPLC-ECD Method for the Analysis of Captopril. Talanta 2011, 83, 1037–1049. DOI: 10.1016/j.talanta.2010.11.025.
   PubMed Web of Science ®Google Scholar
• Christian, J. R.; Patel, K.; Gandhi, T. R. Validation and Experimental Design Assisted Robustness Testing of RPLC Method for the Simultaneous Analysis of Brinzolamide and Brimonidine Tartrate in an Ophthalmic Dosage Form. IJPS 2016, 78, 631–640. DOI: 10.4172/pharmaceutical-sciences.1000162.
   Google Scholar
• Attimarad, M.; Venugopala, K. N.; SreeHarsha, N.; Aldhubiab, B. E.; Nair, A. B. Validation of Rapid RP-HPLC Method for Concurrent Quantification of Amlodipine and Celecoxib in Pure and Formulation Using an Experimental Design. Microchem. J. 2020, 152, 104365. DOI: 10.1016/j.microc.2019.104365.
   Web of Science ®Google Scholar
• Jayaraman, K.; Rajendran, A. K.; Kumar, G. S.; Bhutani, H. A Methodology Employing Retention Modeling for Achieving Control Space in Liquid Chromatography Method Development Using Quality by Design Approach. J. Chromatogr. A 2021, 1635, 461658. DOI: 10.1016/j.chroma.2020.461658.
   PubMed Web of Science ®Google Scholar
• Alkhateeb, F. L.; Wilson, I.; Maziarz, M.; Rainville, P. Ultra High-Performance Liquid Chromatography Method Development for Separation of Formoterol, Budesonide, and Related Substances Using an Analytical Quality by Design Approach. J. Pharm. Biomed. Anal. 2021, 193, 113729. DOI: 10.1016/j.jpba.2020.113729.
   PubMed Web of Science ®Google Scholar
• Ferencz, E.; Zöldhegyi, A.; Kelemen, É. K.; Obreja, M.; Urkon, M.; Sipos, E.; Tóth, G.; Molnár, I.; Szabó, Z. I. Analytical Quality by Design-Compliant Retention Modeling for Exploring Column Interchangeabilities in Separating Ezetimibe and Its Related Substances. J. Chromatogr. A 2022, 1682, 463494. DOI: 10.1016/j.chroma.2022.463494.
   PubMed Web of Science ®Google Scholar
• Yuill, E. M.; Ileka, K. M.; La Cruz, T. E.; Li, J.; Shackman, J. G.; Tattersall, P. I.; Zang, J. Leveraging AQbD Principles for Development of Challenging Drug Substance Stability-Indicating Methods. Org. Process Res. Dev. 2021, 25, 1431–1439. DOI: 10.1021/acs.oprd.1c00121.
   Web of Science ®Google Scholar
• Asma, N.; Maddeppungeng, N. M.; Raihan, M.; Erdiana, A. P.; Himawan, A.; Permana, A. D. New HPLC-UV Analytical Method for Quantification of Metronidazole: Application to Ex Vivo Ocular Kinetic Assessments following the Administration of Thermosensitive Ocular in Situ Gel. Microchem. J. 2022, 172, 106929. DOI: 10.1016/j.microc.2021.106929.
   Web of Science ®Google Scholar
• Ferencz, E.; Kelemen, É.; Obreja, M.; Sipos, E.; Vida, S.; Urkon, M.; Szabó, Z. Computer-Assisted UHPLC Method Development and Optimization for the Determination of Albendazole and Its Related Substances. J. Pharm. Biomed. Anal. 2021, 203, 114203. DOI: 10.1016/j.jpba.2021.114203.
   PubMed Web of Science ®Google Scholar
• Kamal, A. H.; El-Malla, S. F.; Hammad, S. F. A Review on UV Spectrophotometric Methods for Simultaneous Multicomponent Analysis. Eur. J. Pharm. Med. Res. 2016, 3, 348–360.
   Google Scholar
• Ashok, P. K.; Dinkar, F. S. Determination and Development of UV-Spectrophotometric Method for the Amodiquine Hydrochloride by Using Quality by Design (QBD) Approach. Asian J. Pharm. Anal. 2019, 9, 113–117. DOI: 10.5958/2231-5675.2019.00021.8.
   Google Scholar
• Panda, S. S.; Rath, J.; Bera, V. V. R. K. QbD Driven Development and Validation of UV Spectrophotometric Method for Estimation of Paliperidone in Extended Release Tablet Dosage Form. Anal. Chem. Lett. 2018, 8, 510–518. DOI: 10.1080/22297928.2018.1446845.
   Google Scholar
• Ahmed, R.; Hadad, G.; El-Gendy, A.; Ashour, A. Spectrophotometric Method for Determination of Glucosamine Sulphate in Dosage Forms by Derivatization Using Quality by Design Approach. Rec. Pharm. Biomed. Sci. 2018, 2, 34–46. DOI: 10.21608/rpbs.2018.4273.1006.
   Google Scholar
• Mastanamma, S.; Saidulu, P.; Prathibha, L. Analytical Quality by Design Approach for Development of UV-Spectrophotometric Method in the Estimation of Lamivudine from Tablet Dosage Form. Int. J. PharmTech Res. 2016, 9, 399–406.
   Google Scholar
• Kumar, M.; Shukla, A. K.; Bishnoi, R. S.; Jain, C. P. Development of UV Spectrophotometric Method for the Determination of Benidipine Hydrochloride by Using Quality by Design (QbD) Approach. Int. J. App. Pharm. 2018, 10, 92–97. DOI: 10.22159/ijap.2018v10i4.26623.
   PubMedGoogle Scholar
• Abd-Alaah, H. J.; Hamody, A. S. Design of Experiments Model for Optimization of Spectrophotometric Determination of Phenylephrine Hydrochloride in Pure and Pharmaceutical Formulations Using P-Bromanil. J. Pharm. Sci. Res. 2018, 11, 501–507.
   Google Scholar
• Jadhav, M. L.; Tambe, S. R. Implementation of QbD Approach to the Analytical Method Development and Validation for the Estimation of Propafenone Hydrochloride in Tablet Dosage Form. Chromatogr. Res. Int. 2013, 2013, 1–9. DOI: 10.1155/2013/676501.
   Google Scholar
• Bhusnure, O. G.; Dongare, R. B.; Gholve, S. B.; B, M. A.; Shette, R. S. QbD Approach for Analytical Method Development and Validation of Bisoprolol Fumarate by Spectroscopic Method. Int. J. Pharm. Biol. Sci. 2018, 8, 779–792.
   Google Scholar
• Bhusnure, O. G.; Fasmale, R. N.; Gandge, N. V.; Gholve, S. B.; Giram, P. S. QbD Approach for Analytical Method Development and Validation of Serotonin by Spectroscopic Method. Int. J. Pharm. Pharm. Res. 2017, 10, 98–117.
   Google Scholar
• Bhusnure, O. G., Shinde, N. G.; Gholve, S. G.; Giram, P. S. QbD Approach for Analytical Method Development and Validation of Melatonin by Spectroscopic Method Bhusnure. J. Pharm. Res. 2017, 11, 464–471.
   Google Scholar
• Jadhav, M. L.; Tambe, S. R.; Girase, M. V. Analytical Quality by Design Approach for Development of UV Spectrophotometric Methods in the Estimation of Trospium Chloride from Capsule Dosage Form. Int. J. Pharm. Pharm. Sci. 2014, 6, 530–533.
   Google Scholar
• Singh, A.; Hinge, M. Spectrophotometric Determination of Beclomethasone Dipropionate in Its Pharmaceutical Dosage Form Using Quality by Design Approach. J. Pharm. Sci. Biosci. Res. 2020, 10, 113–119.
   Google Scholar
• Wani, Y. B.; Patil, D. D. An Experimental Design Approach for Optimization of Spectrophotometric Method for Estimation of Cefixime Trihydrate Using Ninhydrin as Derivatizing Reagent in Bulk and Pharmaceutical Formulation. J. Saudi Chem. Soc. 2017, 21, S101–S111. DOI: 10.1016/j.jscs.2013.11.001.
   Web of Science ®Google Scholar
• Patil, D. D.; Patil, M. S.; Wani, Y. B. Spectrophotometric Method for Pregabalin Determination: An Experimental Design Approach for Method Development. J. Assoc. Arab Univ. Basic Appl. Sci. 2016, 21, 31–37. DOI: 10.1016/j.jaubas.2015.03.002.
   Google Scholar
• Of, O. Spectrophotometric Quantification of Vilazodone Spectrophotometric Quantification of Vilazodone Hydrochloride in Pharmaceutical Dosage Form Using Quality by Design Approach. Malaysian J. Anal. Sci. 2015, 19, 920–929.
   Google Scholar
• Panda, S. S.; Beg, S.; Varaha, R.; Kumar, V. B.; Gain, A. Spectrophotometric Determination of Sertaconazole Nitrate in Pharmaceutical Dosage Form Using Quality by Design (QbD) Framework. J. Bioanal. Biomed. 2015, 09, 5. DOI: 10.4172/1948-593X.1000185.
   Google Scholar
• K. Adiki, S.; M, P.; Dey, B.; Katakam, P.; H. Assaleh, F.; T. Hwisa, N.; K. Singla, R.; R. Chandu, B. Design of Experiment Assisted UV-Visible Spectrophotometric and RP-HPLC Method Development for Ambrisentan Estimation in Bulk and Formulations. WJAC 2014, 2, 23–30. DOI: 10.12691/wjac-2-2-2.
   Google Scholar
• Paim, C. S.; Gonçalves, H.; Lange, A.; Miron, D.; Steppe, M. Validation of UV Spectrophotometric Method for Quantitative Determination of Entacapone in Tablets Using Experimental Design of Plackett-Burman for Robustness Evaluation and Comparison with HPLC. Anal. Lett. 2008, 41, 571–581. DOI: 10.1080/00032710801912730.
   Web of Science ®Google Scholar
• Rajendran, A. Design of Preparative-Supercritical Fluid Chromatography. J. Chromatogr. A 2012, 1250, 227–249. DOI: 10.1016/j.chroma.2012.05.037.
   PubMed Web of Science ®Google Scholar
• Andri, B.; Lebrun, P.; Dispas, A.; Klinkenberg, R.; Streel, B.; Ziemons, E.; Marini, R. D.; Hubert, P. Optimization and Validation of a Fast Supercritical Fluid Chromatography Method for the Quantitative Determination of Vitamin D3 and Its Related Impurities. J. Chromatogr. A 2017, 1491, 171–181. DOI: 10.1016/j.chroma.2017.01.090.
   PubMed Web of Science ®Google Scholar
• Dispas, A.; Desfontaine, V.; Andri, B.; Lebrun, P.; Kotoni, D.; Clarke, A.; Guillarme, D.; Hubert, P. Quantitative Determination of Salbutamol Sulfate Impurities Using Achiral Supercritical Fluid Chromatography. J. Pharm. Biomed. Anal. 2017, 134, 170–180. DOI: 10.1016/j.jpba.2016.11.039.
   PubMed Web of Science ®Google Scholar
• Schmidtsdorff, S.; Schmidt, A. H. Simultaneous Detection of Nitrosamines and Other Sartan-Related Impurities in Active Pharmaceutical Ingredients by Supercritical Fluid Chromatography. J. Pharm. Biomed. Anal. 2019, 174, 151–160. DOI: 10.1016/j.jpba.2019.04.049.
   PubMed Web of Science ®Google Scholar
• Kurmi, M.; Jayaraman, K.; Natarajan, S.; Kumar, G. S.; Bhutani, H.; Bajpai, L. Rapid and Efficient Chiral Method Development for Lamivudine and Tenofovir Disoproxil Fumarate Fixed Dose Combination Using Ultra-High Performance Supercritical Fluid Chromatography: A Design of Experiment Approach. J. Chromatogr. A 2020, 1625, 461257. DOI: 10.1016/j.chroma.2020.461257.
   PubMed Web of Science ®Google Scholar
• Petruševska, V.; Krtalić, I.; Rašić, A.; Mornar, A. Development of a Robust SFC Method for Evaluation of Compatibility for a Novel Antituberculotic Fixed-Dose Combination. Anal. Methods 2019, 11, 1777–1787. DOI: 10.1039/C9AY00117D.
   Web of Science ®Google Scholar
• Dispas, A.; Lebrun, P.; Ziemons, E.; Marini, R.; Rozet, E.; Hubert, P. Evaluation of the Quantitative Performances of Supercritical Fluid Chromatography: From Method Development to Validation. J. Chromatogr. A 2014, 1353, 78–88. DOI: 10.1016/j.chroma.2014.01.046.
   PubMed Web of Science ®Google Scholar
• Orlandini, S.; Pasquini, B.; Stocchero, M.; Pinzauti, S.; Furlanetto, S. An Integrated Quality by Design and Mixture-Process Variable Approach in the Development of a Capillary Electrophoresis Method for the Analysis of Almotriptan and Its Impurities. J. Chromatogr. A 2014, 1339, 200–209. DOI: 10.1016/j.chroma.2014.02.088.
   PubMed Web of Science ®Google Scholar
• Orlandini, S.; Pasquini, B.; Gotti, R.; Giuffrida, A.; Paternostro, F.; Furlanetto, S. Analytical Quality by Design in the Development of a Cyclodextrin-Modified Capillary Electrophoresis Method for the Assay of Metformin and Its Related Substances. Electrophoresis 2014, 35, 2538–2545. DOI: 10.1002/elps.201400173.
   PubMed Web of Science ®Google Scholar
• Orlandini, S.; Pasquini, B.; Caprini, C.; Del Bubba, M.; Pinzauti, S.; Furlanetto, S. Analytical Quality by Design in Pharmaceutical Quality Assurance: Development of a Capillary Electrophoresis Method for the Analysis of Zolmitriptan and Its Impurities. Electrophoresis 2015, 36, 2642–2649. DOI: 10.1002/elps.201500155.
   PubMed Web of Science ®Google Scholar
• Niedermeier, S.; Scriba, G. K. E. A Quality by Design-Based Approach to a Capillary Electrokinetic Assay for the Determination of Dextromepromazine and Levomepromazine Sulfoxide as Impurities of Levomepromazine. J. Pharm. Biomed. Anal. 2017, 146, 402–409. DOI: 10.1016/j.jpba.2017.09.003.
   PubMed Web of Science ®Google Scholar
• Pasquini, B.; Orlandini, S.; Villar-Navarro, M.; Caprini, C.; Del Bubba, M.; Douša, M.; Giuffrida, A.; Gotti, R.; Furlanetto, S. Chiral Capillary Zone Electrophoresis in Enantioseparation and Analysis of Cinacalcet Impurities: Use of Quality by Design Principles in Method Development. J. Chromatogr. A 2018, 1568, 205–213. DOI: 10.1016/j.chroma.2018.07.021.
   PubMed Web of Science ®Google Scholar
• Orlandini, S.; Pasquini, B.; Caprini, C.; Del Bubba, M.; Douša, M.; Pinzauti, S.; Furlanetto, S. Enantioseparation and Impurity Determination of Ambrisentan Using Cyclodextrin-Modified Micellar Electrokinetic Chromatography: Visualizing the Design Space within Quality by Design Framework. J. Chromatogr. A 2016, 1467, 363–371. DOI: 10.1016/j.chroma.2016.06.082.
   PubMed Web of Science ®Google Scholar
• Furlanetto, S.; Orlandini, S.; Pasquini, B.; Caprini, C.; Mura, P.; Pinzauti, S. Fast Analysis of Glibenclamide and Its Impurities: Quality by Design Framework in Capillary Electrophoresis Method Development. Anal. Bioanal. Chem. 2015, 407, 7637–7646. DOI: 10.1007/s00216-015-8921-x.
   PubMed Web of Science ®Google Scholar
• Krait, S.; Heuermann, M.; Scriba, G. K. E. Development of a Capillary Electrophoresis Method for the Determination of the Chiral Purity of Dextromethorphan by a Dual Selector System Using Quality by Design Methodology. J. Sep. Sci. 2018, 41, 1405–1413. DOI: 10.1002/jssc.201701166.
   PubMed Web of Science ®Google Scholar
• Krait, S.; Scriba, G. K. E. Quality by Design-Assisted Development of a Capillary Electrophoresis Method for the Chiral Purity Determination of Dexmedetomidine. Electrophoresis 2018, 39, 2575–2580. DOI: 10.1002/elps.201800100.
   PubMed Web of Science ®Google Scholar
• Krait, S.; Douša, M.; Scriba, G. K. E. Quality by Design-Guided Development of a Capillary Electrophoresis Method for the Chiral Purity Determination of Ambrisentan. Chromatographia 2016, 79, 1343–1350. DOI: 10.1007/s10337-016-3137-6.
   Web of Science ®Google Scholar
• Orlandini, S.; Pasquini, B.; Del Bubba, M.; Pinzauti, S.; Furlanetto, S. Quality by Design in the Chiral Separation Strategy for the Determination of Enantiomeric Impurities: Development of a Capillary Electrophoresis Method Based on Dual Cyclodextrin Systems for the Analysis of Levosulpiride. J. Chromatogr. A 2015, 1380, 177–185. DOI: 10.1016/j.chroma.2014.12.065.
   PubMed Web of Science ®Google Scholar
• Modroiu, A.; Krait, S.; Hancu, G.; Scriba, G. K. E. Quality by Design-Guided Development of a Capillary Electrophoresis Method for the Chiral Purity Determination of Silodosin. J. Pharm. Biomed. Anal. 2023, 222, 115117. DOI: 10.1016/j.jpba.2022.115117.
   PubMed Web of Science ®Google Scholar
• Patil, A. S.; Shirkhedkar, A. A. Application of Quality by Design in the Development of HPTLC Method for Estimation of Anagliptin in Bulk and in-House Tablets. Eurasian J. Anal. Chem. 2017, 12, 443–458. DOI: 10.12973/ejac.2017.00181a.
   Google Scholar
• Prajapati, P. B.; Bodiwala, K. B.; Shah, S. A. Analytical Quality-by-Design Approach for the Stability Study of Thiocolchicoside by Eco-Friendly Chromatographic Method. J. Planar. Chromatogr. 2018, 31, 477–487. DOI: 10.1556/1006.2018.31.6.8.
   Web of Science ®Google Scholar
• Gopani, M.; Patel, R. B.; Patel, M. R.; Solanki, A. B. Development of a New High-Performance Thin Layer Chromatographic Method for Quantitative Estimation of Lamivudine and Zidovudine in Combined Tablet Dosage Form Using Quality by Design Approach. J. Liq. Chromatogr. Relat. Technol. 2014, 37, 2420–2432. DOI: 10.1080/10826076.2013.836714.
   Web of Science ®Google Scholar
• Dedhiya, P. P.; Singh, R. S.; Shah, P. J.; Shah, S. A. Development and Validation of High Performance Thin Layer Chromatographic Method for Estimation of Metformin Hydrochloride and Empagliflozin in Combined Tablet Dosage Form Using Quality by Design Approach. Pharma Sci. Monit. 2019, 10, 83–100.
   Google Scholar
• Patel, T. R.; Patel, T. B.; Suhagia, B. N.; Shah, S. A. HPTLC Method for Simultaneous Estimation of Aliskiren, Amlodipine, and Hydrochlorothiazide in Synthetic Mixture Using Quality by Design Approach. J. Liq. Chromatogr. Relat. Technol. 2015, 38, 1546–1554. DOI: 10.1080/10826076.2015.1076461.
   Web of Science ®Google Scholar
• Patel, K. G.; Shah, P. M.; Shah, P. A.; Gandhi, T. R. Validated High-Performance Thin-Layer Chromatographic (HPTLC) Method for Simultaneous Determination of Nadifloxacin, Mometasone Furoate, and Miconazole Nitrate Cream Using Fractional Factorial Design. J. Food Drug Anal. 2016, 24, 610–619. DOI: 10.1016/j.jfda.2016.02.011.
   PubMed Web of Science ®Google Scholar
• Ravichandiran, V.; Sumithra, M. Application of Quality by Design (CCD Technique) for Simultaneous Estimation of Cefixime and Ofloxacin by HPTLC Method. Int. J. Pharm. Pharm. Sci. 2016, 8, 200–208.
   Google Scholar
• Solanki, T.; Shah, P.; Patel, K. Central Composite Design for Validation of Hptlc Method for Simultaneous Estimation of Olmesartan Medoxomil, Amlodipine Besylate and Hydrochlorothiazide in Tablets. Indian J. Pharm. Sci. 2014, 76, 179–187.
   PubMed Web of Science ®Google Scholar
• Prajapati, P.; Patel, H. B.; Shah, S. DoE Based Failure Mode Effect Analysis (FMEA) to Development of Stability Indicating HPTLC Method for Estimation of Apremilast. SN Appl. Sci. 2020, 2, 1–18. DOI: 10.1007/s42452-020-2890-1.
   Web of Science ®Google Scholar
• Mustafa, G.; Baboota, S.; Ali, J.; Ahuja, A. Design Expert-Supported Development and Validation of High-Performance Thin-Layer Chromatographic Stability-Indicating (HPTLC) Method: An Application in Quantitative Analysis of Ropinirole in the Bulk Drug and in Marketed Dosage Forms. J. Pharm. Innov. 2012, 7, 47–55. DOI: 10.1007/s12247-012-9126-x.
   Web of Science ®Google Scholar
• Patel, R. B.; Patel, M. R.; Patel, N. M. Box-Behnken Experimental Design Aided Optimization of Stability Indicating HPTLC-Based Assay Method: Application in Pharmaceutical Dosage Form Containing Model Drugs-Roxithromycin and Ambroxol Hydrochloride. Anal. Chem. Lett. 2019, 9, 816–834. DOI: 10.1080/22297928.2019.1700158.
   Google Scholar
• Shah, P.; Patel, J.; Patel, K.; Gandhi, T. Development and Validation of an HPTLC Method for the Simultaneous Estimation of Clonazepam and Paroxetine Hydrochloride Using a DOE Approach. J. Taibah Univ. Sci. 2017, 11, 121–132. DOI: 10.1016/j.jtusci.2015.11.004.
   Web of Science ®Google Scholar
• Zhang, D. S.; Liu, W.; Li, Y. P.; Hu, C. Q. Establishment and Optimization of an HPTLC Method for the Analysis of Gatifloxacin and Related Substances by Design of Experiment. J. Planar Chromatogr. 2013, 26, 215–225. DOI: 10.1556/JPC.26.2013.3.3.
   Web of Science ®Google Scholar
• Patel, K. G.; Patel, S. G. K.; Shah, P. A.; Tandel, D. B.; Gandhi, T. R. Development and Validation of HPTLC Method along with Forced Degradation Study for the Simultaneous Estimation of Azelastine Hydrochloride and Fluticasone Propionate in Nasal Spray Formulation Using Design of Experiment Approach. IJPER 2019, 54, 155–165. DOI: 10.5530/ijper.54.1.19.
   Google Scholar
• Prajapati, P.; Gami, A.; Shah, S. Analytical Quality Risk Management and DoE Based Development of Robust Chromatographic Method for Simultaneous Estimation of Tizanidine Hydrochloride and Nimesulide in Their Combined Pharmaceutical Dosage Forms. SN Appl. Sci. 2020, 2, 1–12. DOI: 10.1007/s42452-020-2066-z.
   Web of Science ®Google Scholar
• Mustafa, G.; Ahuja, A.; Baboota, S.; Ali, J. Box-Behnken Supported Validation of Stability-Indicating High Performance Thin-Layer Chromatography (HPTLC) Method: An Application in Degradation Kinetic Profiling of Ropinirole. Saudi Pharm. J. 2013, 21, 93–102. DOI: 10.1016/j.jsps.2011.11.006.
   PubMed Web of Science ®Google Scholar
• El-Kimary, E. I.; Ragab, M. A. A. Box-Behnken Response Surface Modeling Assisted Enantiomeric Resolution of Some Racemic β-Blockers Using HPTLC and β-Cyclodextrin as Chiral Mobile Phase Additive: Application to Check the Enantiomeric Purity of Betaxolol. Chirality 2018, 30, 1195–1205. DOI: 10.1002/chir.23012.
   PubMed Web of Science ®Google Scholar
• Manikandan, K.; Lakshmi, K. S. Design of Experiment Approach in Robustness Testing of High Performance Thin Layer Chromatography Method for the Estimation of anti-Inflammatory Drugs in Marketed Tablets. Int. J. Appl. Eng. Res. 2017, 12, 727–733.
   Google Scholar
• Chaudhari, S. R.; Shirkhedkar, A. A. Application of Box-Behnken Design for Validation of High-Performance Thin-Layer Chromatography/Densitometry Method for Robustness Determination of Apremilast in Bulk and in House Tablets. PHME 2017, 9, 09–15. DOI: 10.5530/phm.2018.1.3.
   Google Scholar
• Patel, N.; Parmar, V. K. A Sensitive High-Performance Thin Layer Chromatography Method for Simultaneous Determination of Salbutamol Sulphate and Beclomethasone Dipropionate from Inhalation Product. Pharm. Sci. 2018, 24, 131–140. DOI: 10.15171/PS.2018.20.
   Google Scholar
• Patil, M. R.; Ganorkar, S. B.; Patil, A. S.; Shirkhedkar, A. A.; Surana, S. J. A Converged Pharmaceutical Analysis Supported with Hydrotropy & DoE with Dual HPTLC and Stress Studies for Estimation of Tolvaptan. Microchem. J. 2021, 167, 106328. DOI: 10.1016/j.microc.2021.106328.
   Web of Science ®Google Scholar
• Palandurkar, K.; Bhandre, R.; Boddu, S. H. S.; Harde, M.; Lakade, S.; Kandekar, U.; Waghmare, P. Quality Risk Assessment and DoE - Practiced Validated Stability-Indicating Chromatographic Method for Quantification of Rivaroxaban in Bulk and Tablet Dosage Form. AChrom 2023, 35, 10–20. DOI: 10.1556/1326.2021.00978.
   Google Scholar
• Sinko, P. J. Martin’s Physical Pharmacy and Pharmaceutical Sciences; Troy, D. B., Ed.; Lippincott Williams & Wilkins: Philadelphia, 2006; p 795.
   Google Scholar
• Simões, A.; Miranda, M.; Cardoso, C.; Veiga, F.; Vitorino, C. Rheology by Design: A Regulatory Tutorial for Analytical Method Validation. Pharmaceutics 2020, 12, 820. DOI: 10.3390/pharmaceutics12090820.
   PubMed Web of Science ®Google Scholar
• Chiarentin, L.; Cardoso, C.; Miranda, M.; Vitorino, C. Rheology of Complex Topical Formulations: An Analytical Quality by Design Approach to Method Optimization and Validation. Pharmaceutics 2023, 15, 1810. DOI: 10.3390/pharmaceutics15071810.
   PubMed Web of Science ®Google Scholar
• Miranda, M.; Pais, A. A. C. C.; Cardoso, C.; Vitorino, C. AQbD as a Platform for IVRT Method Development – A Regulatory Oriented Approach. Int. J. Pharm. 2019, 572, 118695. DOI: 10.1016/j.ijpharm.2019.118695.
   PubMedGoogle Scholar
• Suleman, S.; Verheust, Y.; Dumoulin, A.; Wynendaele, E.; D'Hondt, M.; Vandercruyssen, K.; Veryser, L.; Duchateau, L.; De Spiegeleer, B. Gas Chromatographic Method for the Determination of Lumefantrine in Antimalarial Finished Pharmaceutical Products. J. Food Drug Anal. 2015, 23, 552–559. DOI: 10.1016/j.jfda.2015.03.004.
   PubMed Web of Science ®Google Scholar
• Yao, H.; Vancoillie, J.; D'Hondt, M.; Wynendaele, E.; Bracke, N.; De Spiegeleer, B. An Analytical Quality by Design (AQbD) Approach for a l-Asparaginase Activity Method. J. Pharm. Biomed. Anal. 2016, 117, 232–239. DOI: 10.1016/j.jpba.2015.08.042.
   PubMed Web of Science ®Google Scholar
• Hewitt, E.; Rignall, A.; Trone, M. D.; Jackson, P.; Chatfield, M.; Argentine, M.; Wang, Q.; Karmarkar, S.; Pless, A. M.; Williams, Z.; et al. Evaluating Progress in Analytical Quality by Design. Pharm. Technol. 2017, 41, 52–59.
   Google Scholar
• International Council Harmonization (ICH). Analytical Procedure Development and Revision of Q12(R1) Analytical Validation Q14. 2022. https://database.ich.org/sites/default/files/ICH_Q14_Document_Step2_Guideline_2022_0324.pdf
   Google Scholar
• Verch, T.; Campa, C.; Chéry, C. C.; Frenkel, R.; Graul, T.; Jaya, N.; Nakhle, B.; Springall, J.; Starkey, J.; Wypych, J.; Ranheim, T. Analytical Quality by Design, Life Cycle Management, and Method Control. AAPS J. 2022, 24, 34. DOI: 10.1208/s12248-022-00685-2.
   PubMed Web of Science ®Google Scholar