Implementing analytical quality by design in reversed phase-high performance liquid chromatography for simultaneous estimation of teriflunomide and quercetin: Applicability in dual drug loaded topical microemulsion

References

• Haleagrahara, N.; Hodgson, K.; Miranda-Hernandez, S.; Hughes, S.; Kulur, A. B.; Ketheesan, N. Flavonoid Quercetin–Methotrexate Combination Inhibits Inflammatory Mediators and Matrix Metalloproteinase Expression, Providing Protection to Joints in Collagen-Induced Arthritis. Inflammopharmacology 2018, 26, 1219–1232. DOI: 10.1007/s10787-018-0464-2.
   PubMed Web of Science ®Google Scholar
• Jose, A.; Ninave, K. M.; Karnam, S.; Venuganti, V. V. K. Temperature-Sensitive Liposomes for Co-Delivery of Tamoxifen and Imatinib for Synergistic Breast Cancer Treatment. J. Liposome Res. 2018, 29, 153–162. DOI: 10.1080/08982104.2018.1502315.
   PubMed Web of Science ®Google Scholar
• Syed, Ayesha, Karwa, Preeti, Vemula, Kusum Devi, Salwa,  . Multifunctional Nanoparticles Encapsulating Methotrexate and Curcumin for Holistic Management of Rheumatoid Arthritis: In-Vitro and Pre-Clinical Assessment. Drug Dev. Ind. Pharm. 2023, 49 (8), 536–549. DOI: 10.1080/03639045.2023.2245057.
   PubMed Web of Science ®Google Scholar
• Hernandez, A. L.; O’Connor, K. C.; Hafler, D. A. Multiple Sclerosis. In The Autoimmune Diseases: 5th ed.; Academic Press, 2014; pp 735–756. DOI: 10.1016/B978-0-12-384929-8.00052-6.
   Google Scholar
• Aly, L.; Hemmer, B.; Korn, T. From leflunomide to teriflunomide: drug development and immuno-suppressive oral drugs in the treatment of multiple sclerosis. Curr. Neuropharmacol. 2017, 15, 874–891. DOI: 10.2174/1570159X14666161208151525.
   PubMed Web of Science ®Google Scholar
• Cohen, S.; Iqbal, I. Leflunomide. Int. J. Clin. Pract. 2003, 57, 115–120. DOI: 10.1111/J.1742-1241.2003.
   PubMed Web of Science ®Google Scholar
• Anand David, A. V.; Arulmoli, R.; Parasuraman, S. Overviews of Biological Importance of Quercetin: A Bioactive Flavonoid. Pharmacogn. Rev. 2016, 10, 84–89. DOI: 10.4103/0973-7847.194044.
   PubMedGoogle Scholar
• Oboh, G.; Ademosun, A. O.; Ogunsuyi, O. B. Quercetin and Its Role in Chronic Diseases. Adv. Exp. Med. Biol. 2016, 929, 377–387. DOI: 10.1007/978-3-319-41342-6_17.
   PubMed Web of Science ®Google Scholar
• Javadi, F.; Ahmadzadeh, A.; Eghtesadi, S.; Aryaeian, N.; Zabihiyeganeh, M.; Rahimi Foroushani, A.; Jazayeri, S. The Effect of Quercetin on Inflammatory Factors and Clinical Symptoms in Women with Rheumatoid Arthritis: A Double-Blind, Randomized Controlled Trial. J. Am. Coll. Nutr. 2016, 36, 9–15.,. 10.1080/07315724.2016.1140093. DOI: 10.1080/07315724.2016.1140093.
   PubMed Web of Science ®Google Scholar
• Yuan, K.; Zhu, Q.; Lu, Q.; Jiang, H.; Zhu, M.; Li, X.; Huang, G.; Xu, A. Quercetin Alleviates Rheumatoid Arthritis by Inhibiting Neutrophil Inflammatory Activities. J. Nutr. Biochem. 2020, 84, 108454. DOI: 10.1016/j.jnutbio.2020.108454.
   PubMed Web of Science ®Google Scholar
• Anita, C.; Munira, M.; Mural, Q.; Shaily, L. Topical Nanocarriers for Management of Rheumatoid Arthritis: A Review. Biomed. Pharmacother. 2021, 141, 111880. DOI: 10.1016/J.BIOPHA.2021.111880.
   PubMed Web of Science ®Google Scholar
• Karnam, S.; Jindal, A. B.; Agnihotri, C.; Singh, B. P.; Paul, A. T. Topical Nanotherapeutics for Treating MRSA-Associated Skin and Soft Tissue Infection (SSTIs). AAPS PharmSciTech 2023, 24, 108. DOI: 10.1208/s12249-023-02563-2.
   PubMed Web of Science ®Google Scholar
• Agrawal, V.; Patel, R.; Patel, M. Tavaborole Microemulsion: New Strategy for the Targeted Treatment of Onychomycosis. J. Drug Deliv. Sci. Technol. 2022, 74, 103494. DOI: 10.1016/j.jddst.2022.103494.
   Web of Science ®Google Scholar
• Vicentini, F. T. M. C.; Vaz, M. M. O. L. L.; Fonseca, Y. M.; Bentley, M. V. L. B.; Fonseca, M. J. V. Characterization and Stability Study of a Water-in-Oil Microemulsion Incorporating Quercetin. Drug Dev. Ind. Pharm. 2011, 37, 47–55. DOI: 10.3109/03639045.2010.491078.
   PubMed Web of Science ®Google Scholar
• Censi, R.; Martena, V.; Hoti, E.; Malaj, L.; Di Martino, P. Permeation and Skin Retention of Quercetin from Microemulsions Containing Transcutol® P. Drug Dev. Ind. Pharm. 2012, 38, 1128–1133. DOI: 10.3109/03639045.2011.641564.
   PubMed Web of Science ®Google Scholar
• Rule, G. S.; Rockwood, A. L.; Johnson-Davis, K. L. LC-MS/MS Method for the Quantification of the Leflunomide Metabolite, Teriflunomide, in Human Serum/Plasma. Methods Mol. Biol. 2019, 1872, 75–83. DOI: 10.1007/978-1-4939-8823-5_8.
   PubMedGoogle Scholar
• Kumar, V. D.; Verma, P. R. P.; Singh, S. K.; Viswanathan, S. LC-ESI-MS/MS Analysis of Quercetin in Rat Plasma after Oral Administration of Biodegradable Nanoparticles. Biomed. Chromatogr. 2015, 29, 1731–1736. DOI: 10.1002/bmc.3486.
   PubMed Web of Science ®Google Scholar
• T. S.V.; LastName,   B. M.G View of Novel Uv Spectrophotometric Method for the Determination of Teriflunomide in Tablet Dosage Form. Int. J. Curr. Pharm. Res. 2019, 11, 81–84.
   Google Scholar
• Dowd, L. E. Spectrophotometric Determination of Quercetin. Anal. Chem. 1959, 31, 1184–1187. DOI: 10.1021/ac60151a033.
   Google Scholar
• Kashid, A. M.; Polshettiwar, P. P.; Bhosale, K. M. Analytical Method Development and Validation of Teriflunomide Active Pharmaceutical Ingredient by RP-UHPLC. Asian J. Pharm. Anal. 2022, 12, 166–172. DOI: 10.52711/2231-5675.2022.00028.
   Google Scholar
• Abdelkawy, K. S.; Balyshev, M. E.; Elbarbry, F. A New Validated HPLC Method for the Determination of Quercetin: Application to Study Pharmacokinetics in Rats. Biomed. Chromatogr. 2017, 31, 1–8. DOI: 10.1002/bmc.3819.
   Google Scholar
• Pandey, S.; Mahtab, A.; Singh, A.; Ahmad, F. J.; Aqil, M.; Talegaonkar, S. Development and Validation of Stability Indicating Reversed-Phase Liquid Chromatographic Method for Simultaneous Quantification of Methotrexate and Teriflunomide in Nanoparticles and Marketed Formulation. Biomed. Chromatogr. 2018, 32, e4372. DOI: 10.1002/bmc.4372.
   PubMed Web of Science ®Google Scholar
• Ramaswamy, S.; Gowthamarajan, K.; Priyanka Dwarampudi, L.; Bhaskaran, M.; Kadiyala, M. Analytical Method Development, Validation and Forced Degradation Studies for Rutin, Quercetin, Curcumin, and Piperine by RP-UFLC Method. Drug Dev. Ind. Pharm. 2021, 47, 562–568. DOI: 10.1080/03639045.2021.1892740.
   PubMed Web of Science ®Google Scholar
• Adin, S. N.; Gupta, I.; Aqil, M.; Mujeeb, M. Application of QbD Based Approach in Development and Validation of RP-HPLC Method for Simultaneous Estimation of Methotrexate and Baicalin in Dual-Drug-Loaded Liposomes. Biomed. Chromatogr. 2023, 37, e5581. DOI: 10.1002/bmc.5581.
   PubMed Web of Science ®Google Scholar
• Gupta, I.; Adin, S. N.; Aqil, M.; Mujeeb, M.; Akhtar, M. Application of QbD-Based Approach to the Development and Validation of an RP-HPLC Method for Simultaneous Estimation of Pregabalin and Naringin in Dual-Drug Loaded Liposomes. Biomed. Chromatogr. 2023, 37, e5623. DOI: 10.1002/bmc.5623.
   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
• Shah, J.; Kotadiya, R.; Patel, R. Analytical Quality by Design-Based Robust RP-HPLC Method for Quantitative Estimation of Pregabalin and Etoricoxib in Fixed-Dose Combination Tablet Formulation. J. AOAC Int. 2022, 105, 1536–1547. DOI: 10.1093/jaoacint/qsac082.
   PubMed Web of Science ®Google Scholar
• Kochling, J.; Wu, W.; Hua, Y.; Guan, Q.; Castaneda-Merced, J. A Platform Analytical Quality by Design (AQbD) Approach for Multiple UHPLC-UV and UHPLC–MS Methods Development for Protein Analysis. J. Pharm. Biomed. Anal. 2016, 125, 130–139. DOI: 10.1016/j.jpba.2016.03.031.
   PubMed Web of Science ®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, e01006. DOI: 10.1590/s2175-97902018000001006.
   Web of Science ®Google Scholar
• Patel, R. B.; Patel, M. R, Department of Pharmaceutical Chemistry and Analysis, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology (CHARUSAT), Changa -388 421, Gujarat, India. A Novel Validated Stability Indicating Analytical Hptlc Method for Quantitation of Hydrochlorothiazide and Lisinopril in Tablet Formulation. Ind. DRU 2022, 59, 47–51. DOI: 10.53879/id.59.06.11791.
   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
• Ahmed, D. A.; Hussein, O. G.; Rezk, M. R.; Abdelkawy, M.; Rostom, Y. Prostateive Merger between Green Analytical Approaches and Quality- by- Design for Alcaftadine Determination in Eye Drops and Rabbit Aqueous Humor; Application to Stability Study by Two Validated Chromatographic Methods. Microchem. J. 2024, 196, 109717. DOI: 10.1016/j.microc.2023.109717.
   Web of Science ®Google Scholar
• Patel, R.; Patel, N.; Patel, M. Design of Experiment Centered Multivariate Optimization Strategy for RP-HPLC Method to Quantitate Retapamulin in Topical Cream and Microemulsion. Pharm Sci. 2020, 27, 219–229. DOI: 10.34172/PS.2020.85.
   Google Scholar
• Patani, N.; Patel, M.; Patel, R.; Correspondence, M.; Patel, R. Development and Validation of HPLC Methodology for Quantitative Estimation of Efinaconazole in Topical Pharmaceutical Formulation Prepared in-House for the Treatment of Onychomycosis. Sep. Sci. Plus. 2020, 3, 375–383. DOI: 10.1002/sscp.202000019.
   Web of Science ®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. 24. DOI: 10.1208/S12248-022-00685-2/FIGURES/4.
   PubMed Web of Science ®Google Scholar
• International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use Ich Harmonised Tripartite Guideline Validation Of Analytical Procedures: Text And Methodology Q2(R1). 1994, pp 1–13.
   Google Scholar
• Vikas, A.; Rashmin, P.; Mrunali, P.; Sandip, M.; Kaushik, T. RP-HPLC Method for Quantitative Estimation of Efinaconazole in Topical Microemulsion and Microemulsion-Based-Gel Formulations and in Presence of Its Degradation Products. Microchem. J. 2020, 155, 104753. DOI: 10.1016/j.microc.2020.104753.
   Web of Science ®Google Scholar
• Baertschi, S. W.; Alsante, K. M.; Tønnesen, H. H. A Critical Assessment of the ICH Guideline on Photostability Testing of New Drug Substances and Products (Q1B): Recommendation for Revision. J. Pharm. Sci. 2010, 99, 2934–2940. DOI: 10.1002/JPS.22076.
   PubMed Web of Science ®Google Scholar
• Peng, J.; Dong, W. J.; Li, L.; Xu, J. M.; Jin, D. J.; Xia, X. J.; Liu, Y. L. Effect of High-Pressure Homogenization Preparation on Mean Globule Size and Large-Diameter Tail of Oil-in-Water Injectable Emulsions. J. Food Drug Anal. 2015, 23, 828–835. DOI: 10.1016/j.jfda.2015.04.004.
   PubMed Web of Science ®Google Scholar
• Rashid, S. A.; Bashir, S.; Naseem, F.; Farid, A.; Rather, I. A.; Hakeem, K. R. Olive Oil Based Methotrexate Loaded Topical Nanoemulsion Gel for the Treatment of Imiquimod Induced Psoriasis-like Skin Inflammation in an Animal Model. Biology (Basel) 2021, 10, 1121. DOI: 10.3390/biology10111121.
   PubMedGoogle Scholar
• Wadie, M.; Abdel-Moety, E. M.; Rezk, M. R.; Tantawy, M. A. Eco-Friendly Chiral HPLC Method for Determination of Alfuzosin Enantiomers and Solifenacin in Their Newly Pharmaceutical Combination: Method Optimization via Central Composite Design. Microchem. J. 2021, 165, 106095. DOI: 10.1016/j.microc.2021.106095.
   Web of Science ®Google Scholar
• Rostom, Y.; Rezk, M. R.; Wadie, M.; Abdel-Moety, E. M.; Marzouk, H. M. State-of-the-Art Mathematically Induced Filtration Approaches for Smart Spectrophotometric Assessment of Silodosin and Solifenacin Mixture in Their New Challenging Formulation: Multi-Tool Greenness and Whiteness Evaluation. Spectrochim Acta A Mol. Biomol. Spectrosc. 2024, 307, 123650. DOI: 10.1016/j.saa.2023.123650.
   PubMed Web of Science ®Google Scholar
• Tantawy, M. A.; Weshahy, S. A.; Wadie, M.; Rezk, M. R. Eco-Friendly Spectrophotometric Methods for Assessment of Alfuzosin and Solifenacin in Their New Pharmaceutical Formulation; Green Profile Evaluation via Eco-Scale and GAPI Tools. Curr. Pharm. Anal. 2021, 17, 1093–1103. DOI: 10.2174/1573412916999200730005740.
   Web of Science ®Google Scholar
• Rostom, Y.; Wadie, M.; Rezk, M. R.; Marzouk, H. M.; Abdel-Moety, E. M. Fingerprinting and Iso-Absorptive Resolution Techniques for the Spectrally Overlapping Dutasteride and Silodosin Mixture: Content Uniformity Testing along with Greenness Profile Assessment. Spectrochim Acta A Mol. Biomol. Spectrosc. 2022, 273, 121063. DOI: 10.1016/J.SAA.2022.121063.
   PubMed Web of Science ®Google Scholar
• Nadella, N. P.; Ratnakaram, V. N.; Srinivasu, N. Quality-by-Design-Based Development and Validation of a Stability-Indicating UPLC Method for Quantification of Teriflunomide in the Presence of Degradation Products and Its Application to in-Vitro Dissolution. J. Liq. Chromatogr. Relat. Technol. 2017, 40, 517–527. DOI: 10.1080/10826076.2017.1330211.
   Web of Science ®Google Scholar
• El-Said, K. S.; Atta, A.; Mobasher, M. A.; Germoush, M. O.; Mohamed, T. M.; Salem, M. M. Quercetin Mitigates Rheumatoid Arthritis by Inhibiting Adenosine Deaminase in Rats. Mol. Med. 2022, 28 (1), 24 DOI: 10.1186/s10020-022-00432-5.
   Web of Science ®Google Scholar
• Ghasemi, M.; Rahmani, M.; Khajeh, M. Development of a Liquid-Phase Microextraction Method Prior to HPLC Analysis of Quercetin in Food Samples. J. Chromatogr. Sci. 2023, bmad028, DOI: 10.1093/CHROMSCI/BMAD028.
   PubMed Web of Science ®Google Scholar
• Wadie, M.; Abdel-Moety, E. M.; Rezk, M. R.; Marzouk, H. M. A Novel Eco-Friendly HPLC Method with Dual Detection Modes for Versatile Quantification of Dutasteride and Silodosin in Pharmaceutical Formulation, Dissolution Testing and Spiked Human Plasma. Microchem. J. 2024, 197, 109753. DOI: 10.1016/j.microc.2023.109753.
   Web of Science ®Google Scholar
• Mehta, B.; Prajapat, P.; Gohil, Y. Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Teriflunomide in Active Pharmaceutical Ingredient. Pharma Innov. J. 2017, 6, 440–449.
   Google Scholar
• Upadhyay Priya Shitalaprasad, *D. V. C. D. B. P. J. P. Development and Validation of Stability Indicating Assay Method for Estimation of Teriflunomide in Tablet Dosage Form. Ndo Am. J. Pharm. Sci. 2018, 05, 3209–3219. DOI: 10.5281/ZENODO.1240480.
   Google Scholar
• Khursheed, R.; Singh, S. K.; Kapoor, B.; Gulati, M.; Wadhwa, S.; Gupta, S.; Prasher, P.; Kumar, D.; Dua, K.; Kumar, L. M. S.; et al. Development and Validation of RP-HPLC Method for Simultaneous Determination of Curcumin and Quercetin in Extracts, Marketed Formulations, and Self-Nanoemulsifying Drug Delivery System. GEN Open 2021, 1, 43–52. https://home.liebertpub.com/regen., DOI: 10.1089/regen.2021.0021.
   Google Scholar
• Sanghavi, N.; Bhosale, S. D.; Malode, Y, MET Institute of Pharmacy (Degree), Bandra (West), Mumbai400050, Maharashtra, India. RP-HPLC Method Development and Validation of Quercetin Isolated from the Plant Tridax Procumbens L. J. Sci. Innov. Res. 2014, 3, 594–597. DOI: 10.31254/jsir.2014.3609.
   Google Scholar