755
Views
0
CrossRef citations to date
0
Altmetric
Review Article

Recent Progresses in Analytical Perspectives of Degradation Studies and Impurity Profiling in Pharmaceutical Developments: An Updated Review

, , ORCID Icon, & ORCID Icon
Pages 1094-1115 | Published online: 02 Feb 2022

References

  • International Conference on Harmonisation (ICH), Impurities in New Drug Products Q3B (R2), IFPMA, Geneva (Switzerland), 2006.
  • International Conference on Harmonisation (ICH), Impurities in New Drug Substances Q3A (R2) IFPMA, Geneva (Switzerland), 2006.
  • International Conference on Harmonisation (ICH), Stability Testing of New Drug Substances and Products Q1A (R2) (Revised Guideline), 2003.
  • International Conference on Harmonisation (ICH), Photostability Testing of New Drug Substances and Products ICH Q1B, 1999.
  • International Conference on Harmonisation (ICH), Stability Testing for New Dosage Forms ICH Q1C, 1997.
  • International Conference on Harmonisation (ICH), Evaluation of Stability Data ICH Q1E, 2004.
  • Müller, L.; Mauthe, R. J.; Riley, C. M.; Andino, M. M.; Antonis, D. D.; Beels, C.; DeGeorge, J.; Knaep, A. G. M. D.; Ellison, D.; Fagerland, J. A.; et al. A Rationale for Determining, Testing, and Controlling Specific Impurities in Pharmaceuticals That Possess Potential for Genotoxicity. Regul. Toxicol. Pharmacol. 2006, 44, 198–211. DOI: 10.1016/j.yrtph.2005.12.001.
  • Gross, J. M. Fanconi Syndrome (Adult Type) Developing Secondary to the Ingestion of Outdated Tetracycline. Ann. Intern. Med. 1963, 58, 523–528. DOI: 10.7326/0003-4819-58-3-523.
  • Betto, P.; Turchetto, L.; Longinotti, L. Allergenic Impurities in Medicinal Preparations Containing Aminopenicillin. I. Ampicillin Sodium. Ann. Ist. Super. Sanita. 1989, 25, 315–317.
  • Romano, A.; Torres, M. J.; Fernandez, J.; Vega, J. M.; Mayorga, C.; Garcia, J.; Blanca, M. Allergic Reactions to Ampicillin. Studies on the Specificity and Selectivity in Subjects with Immediate Reactions. Clin. Exp. Allergy. 1997, 27, 1425–1431. DOI: 10.1046/j.1365-2222.1997.1790983.x
  • McMahon, A. W.; Pratt, R. G.; Hammad, T. A.; Kozlowski, S.; Zhou, E.; Lu, S.; Kulick, C. G.; Mallick, T.; Pan, G. D. Description of Hypersensitivity Adverse Events following Administration of Heparin That Was Potentially Contaminated with Oversulfated Chondroitin Sulfate in Early 2008. Pharmacoepidemiol Drug Saf. 2010, 19, 921–933. DOI: 10.1002/pds.1991.
  • Görög, S. Critical Review of Reports on Impurity and Degradation Product Profiling in the Last Decade. Trends. Analyt. Chem. 2018, 101, 2–16. DOI: 10.1016/j.trac.2017.09.012.
  • Roy, J. Pharmaceutical Impurities—A Mini-Review. AAPs. Pharm. Sci. Tech. 2002, 3, 1–8. DOI: 10.1208/pt030206.
  • The United State Pharmacopeial USP 41. The National Formulary NF 41, 2018; United State Pharmacopeial Convention, Inc.: Rockville, MD, 1990, pp. 1434–1435.
  • Khodaverdi, E.; Golmohammadian, A.; Mohajeri, S. A.; Zohuri, G.; Tekie, M.; Hadizadeh, F. Biodegradable in Situ Gel-Forming Controlled Drug Delivery System Based on Thermosensitive Poly(ε-Caprolactone)-Poly(Ethylene Glycol)-Poly(ε-Caprolactone) Hydrogel. ISRN Pharm. 2012, 2012, 976879. DOI: 5402/2012/976879 DOI: 10.5402/2012/976879.
  • Ahuja, S. S. Assuring Quality of Drugs by Monitoring Impurities. Adv. Drug Deliv. Rev. 2007, 59, 3–11. DOI: 10.1016/j.addr.2006.10.003.
  • Alsante, K. M.; Ando, A.; Brown, R.; Ensing, J.; Hatajik, T. D.; Kong, W.; Tsuda, Y. The Role of Degradant Profiling in Active Pharmaceutical Ingredients and Drug Products. Adv. Drug Deliv. Rev. 2007, 59, 29–37. DOI: 10.1016/j.addr.2006.10.006.
  • Dhangar, K. R.; Jagtap, R. B.; Surana, S. J.; Shirkhedkar, A. A. Impurity Profiling of Drugs towards Safety and Efficacy: Theory and Practice. J. Chil. Chem. Soc. 2017, 62, 3543–3557. DOI: 10.4067/S0717-97072017000200024.
  • Ahuja, S.; Alsante, K. M. Handbook of Isolation and Characterization of Impurities in Pharmaceuticals; Academic Press: Massachusetts, 2003.
  • Smith, R. J.; Webb, M. L. Analysis of Drug Impurities; John Wiley & Sons: New Jersey, 2008.
  • Görög, S. The Importance and the Challenges of Impurity Profiling in Modern Pharmaceutical Analysis. TrAC: Trends. Analyt. Chem. 2006, 25, 755–757. DOI: 10.1016/j.trac.2006.05.011.
  • Khoshneviszadeh, R.; Fazly Bazzaz, B. S.; Rajabi, O. A Colorimetric Method to Measure the Amount of Hydroquinone in Liposomal Formulations. Trend. Pharm. Sci. 2019, 5, 87–92. DOI: 10.30476/TIPS.2019.81853.1007.
  • Singh, S. Forensic Analysis of Compendial Articles: The Tightening Noose, EDQM, USPC, Anticipated Fallouts, GIT Lab. J. Eur. 2007, 11, 38.
  • Glipizide Monograph. In EP, European Pharmacopoeia 6.0, 6th ed.; Council of Europe: Strasbourg, France, 2008; pp. 1977–1979.
  • Available from: http://www.usp.org/usp-nf/pending-monographs. Accessed 19 Mar 2012.
  • Bartos, D.; Gorog, S. Recent Advances in the Impurity Profiling of Drugs. CPA. 2008, 4, 215–230. DOI: 10.2174/157341208786306199.
  • Liu, D. Q.; Wu, L.; Sun, M.; MacGregor, P. A. On-Line H/D Exchange LC-MS Strategy for Structural Elucidation of Pharmaceutical Impurities. J. Pharm. Biomed. Anal. 2007, 44, 320–329. DOI: 10.1016/j.jpba.2007.01.019.
  • Baertschi, S. W. Analytical Methodologies for Discovering and Profiling Degradation-Related Impurities. Trends. Analyt. Chem. 2006, 25, 758–767. DOI: 10.1016/j.trac.2006.05.012.
  • Sobhani, Z.; Emami, S. A.; Rajabi, O. Comparison between HPLC and HPTLC Densitometry for the Determination of Spinosin from Ziziphus Jujuba Mill. Fruit Extracts. J. Liq. Chromatogr. Relat. Technol. 2020, 43, 10–16. DOI: 10.1080/10826076.2019.1576140.
  • Ganorkar, A.; Gupta, K. Analytical Quality by Design: A Mini Review. Biomed. J. Sci. Tech. Res. 2017, 1, 1555–1559. DOI: 10.26717/BJSTR.2017.01.000484.
  • Monks, K.; Rieger, H.-J.; Molnár, I. Expanding the Term “Design Space” in High Performance Liquid Chromatography (I)). J. Pharm. Biomed. Anal. 2011, 56, 874–879. DOI: 10.1016/j.jpba.2011.04.015.
  • Kamali, H.; Khodaverdi, E.; Hadizadeh, F.; Ghaziaskar, S. Optimization of Phenolic and Flavonoid Content and Antioxidants Capacity of Pressurized Liquid Extraction from Dracocephalum Kotschyi via Circumscribed Central Composite. J. Supercrit. Fluids. 2016, 107, 307–314. DOI: 10.1016/j.supflu.2015.09.028.
  • Baertschi, S. W.; Alsante, K. M.; Reed, R. A. Pharmaceutical Stress Testing: Predicting Drug Degradation; CRC Press: Florida, 2016.
  • Alsante, K. M.; Friedmann, R. C.; Hatajik, T. D.; Lohr, L. L.; Sharp, T. R.; Snyder, K. D.; Szczesny, E. J. Degradation and Impurity Analysis for Pharmaceutical Drug Candidates. In Handbook of Modern Pharmaceutical Analysis. 2001, 3, 85–172.
  • Kogawa, A. C.; Salgado, H. R. N. Impurities and Forced Degradation Studies: A Review. Curr. Pharm. Anal. 2016, 12, 18–24.
  • Ingale, S. J.; Sahu, C. M.; Paliwal, R. T.; Vaidya, S.; Singhai, A. K. Advance Approaches for the Impurity Profiling of Pharmaceutical Drugs: A Review. Int. J. Pharm. Life. Sci. 2011, 2, 955–962.
  • Jain, D.; Basniwal, P. K. Forced Degradation and Impurity Profiling: Recent Trends in Analytical Perspectives. J. Pharm. Biomed. Anal. 2013, 86, 11–35. DOI: 10.1016/j.jpba.2013.07.013.
  • Shelke, M.; Deshpande, S. S.; Sharma, S. Quinquennial Review of Progress in Degradation Studies and Impurity Profiling: An Instrumental Perspective Statistics. Crit. Rev. Anal. Chem. 2020, 50, 226–253. DOI: 10.1080/10408347.2019.1615863.
  • Iliou, K.; Malenović, A.; Loukas, Y. L.; Dotsikas, Y. Analysis of Potential Genotoxic Impurities in Rabeprazole Active Pharmaceutical Ingredient via Liquid Chromatography-Tandem Mass Spectrometry, following Quality-By-Design Principles for Method Development. J. Pharm. Biomed. Anal. 2018, 149, 410–418. DOI: 10.1016/j.jpba.2017.11.037.
  • Filip, K.; Łaszcz, M.; Leś, A.; Chmiel, J. Process-Related Impurities of Eplerenone: Determination and Characterisation by HPLC Methods and Raman Spectroscopy. J. Pharm. Biomed. Anal. 2018, 159, 466–476. DOI: 10.1016/j.jpba.2018.07.028.
  • Zhuang, T.; Zhang, W.; Cao, L.; He, K.; Wang, Y.; Li, J.; Chen, L.; Liu, B.; Zhang, G. Isolation, Identification and Characterization of Two Novel Process-Related Impurities in Olanzapine. J. Pharm. Biomed. Anal. 2018, 152, 188–196. DOI: 10.1016/j.jpba.2018.01.026.
  • Arla, R. Development and Validation of Stability-Indicating Gas Chromatography Method for the Quantitative Determination of Ethylhexylglycerin and Its Impurities in Bulk and Pharmaceutical Dosage Forms. Asian. J. Pharm. 2018, 12, 243–250. DOI: 10.22377/ajp.v12i01.2068.
  • Magar, L. P.; Zaware, B. H.; More, K.; Sharma, B.; Shikhare, K.; Kamath, R.; Patil, P.; Gupta, L. Isolation, Synthesis and Characterization of Novel Process Related Impurities in Cetirizine Dihydrochloride by Mass and NMR Spectrometry. 2018.
  • Wolff, F. C.; Dillenburg, T. L.; Venzon Antunes, M.; Linden, R.; Comparsi Wagner, S.; Verza, S. G. Characterization of Imatinib Mesylate Formulations Distributed in South American Countries: Determination of Genotoxic Impurities by UHPLC-MS/MS and dissolution profile . Biomed. Chromatogr. 2018, 32, e4222. DOI: 10.1002/bmc.4222.
  • Wu, W.; Tang, M.-H.; Tang, H.; Chen, K.; Fu, J.; Wang, L.; Xue, L.-L.; Peng, A.; Ye, H.; Chen, L.-J. Identification, Characterization and HPLC Quantification of Formulation-Related Impurities of Honokiol, an Antitumor Natural Drug Candidate in Clinical Trials. J. Pharm. Biomed. Anal. 2018, 153, 186–192. DOI: 10.1016/j.jpba.2018.02.033.
  • Wang, J.; Zheng, S.; Xu, Y.; Hu, H.; Shen, M.; Tang, L. Development of a Novel HPLC Method for the Determination of the Impurities in Desonide Cream and Characterization of Its Impurities by 2D LC-IT-TOF MS. J. Pharm. Biomed. Anal. 2018, 161, 399–406. DOI: 10.1016/j.jpba.2018.08.055.
  • Devrukhakar, P. S.; M, S. S.; G, S.; R, S. Proposal of Degradation Pathway with Toxicity Prediction for Hydrolytic and Photolytic Degradation Products of Timolol. J. Pharm. Biomed. Anal. 2018, 154, 7–15. DOI: 10.1016/j.jpba.2018.02.057.
  • Wahl, O.; Cleynhens, J.; Verbruggen, A. M.; Holzgrabe, U. Impurity Profiling of N,N'-Ethylenebis-l-Cysteine Diethyl Ester (Bicisate). J. Pharm. Biomed. Anal. 2018, 150, 132–136. DOI: 10.1016/j.jpba.2017.11.078.
  • Van Heugten, A.; De Boer, W.; De Vries, W.; Markesteijn, C.; Vromans, H. Development and Validation of a Stability-Indicating HPLC-UV Method for the Determination of Triamcinolone Acetonide and Its Degradation Products in an Ointment Formulation. J. Pharm. Biomed. Anal. 2018, 149, 265–270. DOI: 10.1016/j.jpba.2017.11.026.
  • Kushwah, B. S.; Gupta, J.; Singh, D. K.; Kurmi, M.; Sahu, A.; Singh, S. Characterization of Solution Stress Degradation Products of Aliskiren and Prediction of Their Physicochemical and ADMET Properties. Eur. J. Pharm. Sci. 2018, 121, 139–154. DOI: 10.1016/j.ejps.2018.05.021.
  • Baira, S. M.; Sigalapalli, D. K.; Bathini, N. B.; Srinivas, R.; Talluri, M. K. LC/QTOF/MS/MS Characterization, Molecular Docking and In Silico Toxicity Prediction Studies on Degradation Products of Anagliptin. J. Pharm. Biomed. Anal. 2018, 159, 92–99. DOI: 10.1016/j.jpba.2018.06.036.
  • Yuan, Y.; Li, Y.-B.; Tai, Z.-F.; Xie, Y.-P.; Pu, X.-F.; Gao, J. Study of Forced Degradation Behavior of Pramlintide Acetate by HPLC and LC-MS. J. Food Drug Anal. 2018, 26, 409–415. DOI: 10.1016/j.jfda.2017.07.009.
  • Ghodke, S. S. Stability Indicating RP-HPLC Method for Simvastatin and Sitagliptin Phosphate with Degradation Studies in Marketed Pharmaceutical Hypo-Cholesterol and Antidiabetic Tablets. Int. J. Pharm. Chem. Bio. Sci. 2018, 08, 99–109.
  • Saita, M. G.; Aleo, D.; Melilli, B.; Mangiafico, S.; Cro, M.; Sanfilippo, C.; Patti, A. pH-Dependent Stability of Azithromycin in Aqueous Solution and Structure Identification of Two New Degradation Products. J. Pharm. Biomed. Anal. 2018, 158, 47–53. DOI: 10.1016/j.jpba.2018.05.042.
  • Thummar, M.; Kuswah, B. S.; Samanthula, G.; Bulbake, U.; Gour, J.; Khan, W. Validated Stability Indicating Assay Method of Olaparib: LC-ESI-Q-TOF-MS/MS and NMR Studies for Characterization of Its New Hydrolytic and Oxidative Forced Degradation Products. J. Pharm. Biomed. Anal. 2018, 160, 89–98. DOI: 10.1016/j.jpba.2018.07.017.
  • Ragab, M. A.; Korany, M. A.; Galal, S. M.; Ahmed, A. R. Diode Array Detection for Stability Assessment and Evaluation of Degradation Kinetics of Newly Introduced Sacubitril in Its Supramolecular Complex (Lcz696) with Valsartan. J. Liq. Chromatogr. Relat. Technol. 2018, 41, 33–42. DOI: 10.1080/10826076.2017.1415213.
  • Baira, S. M.; Kalariya, P. D.; Nimbalkar, R.; Garg, P.; Srinivas, R.; Talluri, M. K. Characterization of Forced Degradation Products of Canagliflozine by Liquid Chromatography/Quadrupole Time-of-Flight Tandem Mass Spectrometry and In Silico Toxicity Predictions. Rapid Commun. Mass Spectrom. 2018, 32, 212–220. DOI: 10.1002/rcm.8032.
  • Tiwari, S. K.; Singh, D. K.; Ladumor, M. K.; Chakraborti, A. K.; Singh, S. Study of Degradation Behaviour of Montelukast Sodium and Its Marketed Formulation in Oxidative and Accelerated Test Conditions and Prediction of Physicochemical and Admet Properties of Its Degradation Products Using Admet Predictor™. J. Pharm. Biomed. Anal. 2018, 158, 106–118. DOI: 10.1016/j.jpba.2018.05.040.
  • Bhole, R. P.; Tamboli, F. R. Development and Validation of Stability Indicating HPTLC-MS Method for Estimation of Empagliflozin in Pharmaceutical Dosage Form. Anal. Chem. Lett. 2018, 8, 244–256. DOI: 10.1080/22297928.2017.1404929.
  • Chavan, B. B.; Vijaya Jyothi, P.; Kalariya, P. D.; Srinivas, R.; Talluri, M. V. N. K. Alcaftadine: Selective Separation and Characterization of Degradation Products by LC–QTOF-MS/MS. Chromatographia. 2018, 81, 631–638. DOI: 10.1007/s10337-018-3489-1.
  • Arous, B.; Al-Mardini, M. A.; Ghazal, H.; Al-Lahham, F. Stability-Indicating Method for the Determination of Rivaroxaban and Its Degradation Products Using LC-MS and TLC. Rese. J. Pharm. Technol. 2018, 11, 212–220. DOI: 10.5958/0974-360X.2018.00040.9.
  • Guvvala, V.; Subramanian, V. C.; Anireddy, J. S.; Konda, M. Novel Degradation Products of Argatroban: Isolation, Synthesis and Extensive Characterization Using NMR and LC-PDA-MS/Q-TOF. J. Pharm. Anal. 2018, 8, 86–95. DOI: 10.1016/j.jpha.2017.07.001.
  • Can, N. Ö. Development of Validated and Stability-Indicating LC-DAD and LC-MS/MS Methods for Determination of Avanafil in Pharmaceutical Preparations and Identification of a Novel Degradation Product by LCMS-IT-TOF. Molecules. 2018, 23, 1771. DOI: 10.3390/molecules23071771.
  • Samanthula, G.; Swain, D.; Sahu, G.; Bhagat, S.; Bharatam, P. Ultra HPLC Method for Fixed Dose Combination of Azilsartan Medoxomil and Chlorthalidone: Identification and In Silico Toxicity Prediction of Degradation Products. J. Anal. Chem. 2018, 73, 560–569. DOI: 10.1134/S1061934818060138.
  • 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.
  • Thummar, M.; Swain, D.; Gananadhamu, S. Separation and Characterization of New Forced Degradation Products of Macitentan: A Dual Endothelin Receptor Antagonist. Chromatographia. 2018, 81, 525–531. DOI: 10.1007/s10337-018-3471-y.
  • Luo, Z.; Chen, X.; Wang, G.; Du, Z.; Ma, X.; Wang, H.; Yu, G.; Liu, A.; Li, M.; Peng, W.; Liu, Y. Development of a Validated HPLC Method for the Quantitative Determination of Trelagliptin Succinate and Its Related Substances in Pharmaceutical Dosage Forms. Eur. J. Pharm. Sci. 2018, 111, 458–464. DOI: 10.1016/j.ejps.2017.10.028.
  • Lu, Y.; Sun, X.; Song, F.; Wang, L.; Song, M.; Hang, T. Impurity Profiling of Varenicline Tartrate by LC-QTOF Mass Spectrometric Techniques during Drug Development. J. Pharm. Biomed. Anal. 2018, 155, 306–313. DOI: 10.1016/j.jpba.2018.03.055.
  • Lago, M. W.; Friedrich, M. L.; Iop, G. D.; Souza, d. T. B.; Azevedo Mello, d. P.; Adams, A. I. H. Capillary Zone Electrophoresis Method to Assay Tipranavir Capsules and Identification of Oxidation Product and Organic Impurity by Quadrupole-Time of Flight Mass Spectrometry. Talanta. 2018, 181, 182–189. DOI: 10.1016/j.talanta.2018.01.012.
  • Luo, Z.; Liu, A.; Liu, Y.; Wang, G.; Chen, X.; Wang, H.; Li, M.; Zhang, H.; Qiu, Y.; Zhai, H. Development of a Stability - Indicating HPLC Method for Simultaneous Determination of Ten Related Substances in Vonoprazan Fumarate Drug Substance. J. Pharm. Biomed. Anal. 2018, 149, 133–142. DOI: 10.1016/j.jpba.2017.11.011.
  • Gibala, P.; Douša, M.; Kalužíková, A.; Tkadlecová, M.; Štefko, M.; Kalášek, S.; Břicháč, J. Identification and Structure Elucidation of a New Degradation Impurity in the Multi-Component Tablets of Amlodipine Besylate. J. Pharm. Biomed. Anal. 2019, 162, 112–116. DOI: 10.1016/j.jpba.2018.07.040.
  • Wingert, N. R.; Ellwanger, J. B.; Bueno, L. M.; Gobetti, C.; Garcia, C. V.; Steppe, M.; Schapoval, E. E. 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.
  • Kasimala, B. B.; Anna, V. R.; Mallu, U. R.; Reddy, M. Intended High-Performance Liquid Chromatography Procedure for the Quantification of Norfloxacin and Its Potential Impurities in Active Pharmaceutical Ingredient and Tablet Dosage Forms. Thai. J. Pharm. Sci. 2018, 42, 27–36.
  • Mohan, T. S. S. J.; Mukkanti, K.; Jogia, H. A. Stability Indicating UHPLC Method Development and Validation for Estimation of Eltrombopag and Its Related Impurities in Tablet Dosage Form. Orient. J. Chem. 2018, 34, 1098–1104. DOI: 10.13005/ojc/340262..
  • Siva Kumar, R.; Sravan Kumar, K.; Kondareddy, L.; Yogeshwara, K.; Manish, G.; Jeenet, J.; Nitesh, K. Stability Indicating RP-HPLC Method for Estimation of Potential Impurities in Ledipasvir and Characterization of a New Degradation Impurity. J. Chromatogr. Sci. 2018, 56, 383–395. DOI: 10.1093/chromsci/bmx084.
  • Abou Al-Alamein, A. M.; Abd El-Rahman, M. K.; Abdel-Moety, E. M.; Fawaz, E. M. Green HPTLC-Densitometric Approach for Simultaneous Determination and Impurity-Profiling of Ebastine and Phenylephrine Hydrochloride. Int. J. Pharm. Res. Technol. 2019, 147, 1097–1102. DOI: 10.1016/j.microc.2019.04.043.
  • 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.
  • Kumar, V.; Bhurta, D.; Sharma, A.; Kumar, P.; Bharate, S. B.; Vishwakarma, R. A.; Bharate, S. S. Impurity Profiling of Anticancer Preclinical Candidate, IIIM-290. J. Pharm. Biomed. Anal. 2019, 166, 1–5. DOI: 10.1016/j.jpba.2018.12.027.
  • Nagadeep, J.; Kamaraj, P.; Arthanareeswari, M. Gradient RP-HPLC Method for the Determination of Potential Impurities in Dabigatran Etexilate in Bulk Drug and Capsule Formulations. Arab. J. Chem. 2019, 12, 3431–3443. DOI: 10.1016/j.arabjc.2015.09.006.
  • Kasagić-Vujanović, I.; Jančić-Stojanović, B. Quality by Design Oriented Development of Hydrophilic Interaction Liquid Chromatography Method for the Analysis of Amitriptyline and Its Impurities. J. Pharm. Biomed. Anal. 2019, 173, 86–95. DOI: 10.1016/j.jpba.2019.05.026.
  • Awasthi, A. K.; Kumar, L.; Tripathi, P.; Golla, M.; Reddy, C. S.; Kumar, P. Prospects to the Formation and Control of Potential Dimer Impurity E of pantoprazole sodium sesquihydrate. J. Pharm. Anal. 2019, 9, 170–177. DOI: 10.1016/j.jpha.2019.02.002.
  • Yang, W.; Yang, X.; Shi, F.; Liao, Z.; Liang, Y.; Yu, L.; Wang, R.; Li, Q.; Bi, K. Qualitative and Quantitative Assessment of Related Substances in the Compound Ketoconazole and Clobetasol Propionate Cream by HPLC-TOF-MS and HPLC. J. Pharm. Anal. 2019, 9, 156–162. DOI: 10.1016/j.jpha.2019.02.002.
  • He, L.; Qian, J.; Zhu, P.; Yang, W.; She, Y. Separation and Characterization of Unknown Impurities in Latamoxef Sodium by LC-Q-TOF MS and a Summary of Their Positive-Ion Fragmentation Regularities. J. Pharm. Biomed. Anal. 2019, 175, 112793. DOI: 10.1016/j.jpba.2019.112793.
  • Gopireddy, R. R.; Maruthapillai, A.; Devikala, S.; Tamilselvi, M.; Selvi, J. A.; 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.
  • Kavitapu, D.; Maruthapillai, A.; Devikala, S.; Selvi, J. A.; Tamilselvi, M.; Mahapatra, S.; Kumar, G. P.; Tyagi, P. K. New Rapid Stability Indicating RP-UPLC Method for the Determination of Olaparib, Its Related Substances and Degradation Products in Bulk Drug and Dosage Form. Mater. Today. Proc. 2019, 14, 492–503. DOI: 10.1016/j.matpr.2019.04.172.
  • Kongkiatpaiboon, S.; Duangdee, N.; Chewchinda, S.; Poachanukoon, O.; Amnuaypattanapon, K. Development and Validation of Stability Indicating HPLC Method for Determination of Adrenaline Tartrate. J. King. Saud. Univ. Sci. 2019, 31, 48–51. DOI: 10.1016/j.jksus.2017.05.016.
  • Chavan, B. B.; Sawant, V.; Borkar, R. M.; Ragampeta, S.; Talluri, M. K. Isolation and Structural Characterization of Degradation Products of Afatinib Dimaleate by LC-Q-TOF/MS/MS and NMR: Cytotoxicity Evaluation of Afatinib and Isolated Degradation Products. J. Pharm. Biomed. Anal. 2019, 166, 139–146. DOI: 10.1016/j.jpba.2019.01.004.
  • Guvvala, V.; Subramanian, V. C.; Anireddy, J. S. A Study on Structural Characterization of Degradation Products of Cangrelor Using LC/QTOF/MS/MS and NMR. J. Pharm. Biomed. Anal. 2019, 170, 327–334. DOI: 10.1016/j.jpba.2019.03.031.
  • Gumieniczek, A.; Berecka, A.; Mroczek, T.; Wojtanowski, K.; Dąbrowska, K.; Stępień, K. Determination of Chemical Stability of Sitagliptin by LC-UV, LC-MS and FT-IR Methods. J. Pharm. Biomed. Anal. 2019, 164, 789–807. DOI: 10.1016/j.jpba.2018.11.023.
  • Venkateswararao, Y.; Sujana, K. A Novel Stability Indicating RP-HPLC Method Development and Validation for the Determination of Clopidogrel in Bulk and Its Dosage Forms. Int. J. Pharm. Res. Technol. 2019, 09, 1–11.
  • Azar, Z. J.; Afshar, M. Development and Validation of a Stability-Indicating Ion-Pair RP-HPLC Method for Determination of Bethanechol with UV Detection: Application to Pharmaceutical Analysis. Pharm. Chem. J. 2019, 53, 376–382. DOI: 10.1007/s11094-019-02008-w.
  • Baira, S. M.; Srinivas, R.; Talluri, M. K. Identification and Structural Characterization of Hydrolytic Degradation Products of Alvimopan by LC/QTOF/MS/MS and NMR studies. J. Pharm. Biomed. Anal. 2019, 165, (399–409. DOI: 10.1016/j.jpba.2018.12.035.
  • Veerubhotla, K.; Walker, R. 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.
  • Swarupa, P. G.; Prasad, K.; Babu, K. S.; Kumar, J. S. Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Escitalopram and L-Methylfolate in Bulk and Tablet Dosage Form. RJC. 2019, 12, 2338–2347. DOI: 10.31788/RJC.2019.1245438.
  • Campbell, J. M.; Grinias, K.; Facchine, K.; Igne, B.; Clawson, J.; Peterson, J.; Wolters, A.; Barry, J.; Watson, S.; Leach, K. Analysis of Unstable Degradation Impurities of a Benzodiazepine and Their Quantification without Isolation Using Multiple Linear Regression. J. Pharm. Biomed. Anal. 2019, 167, 1–6. DOI: 10.1016/j.jpba.2019.01.028.
  • Vajjha, S.; Bommuluri, V.; Mohan P, K. V. K.; Rumalla, C. S.; Doddipalla, R.; Kaliyaperumal, M.; Korupolu, R. B. Degradation Studies of Ibrutinib under Stress Conditions: Characterisation and Structural Elucidation of Novel Degradants. J. Pharm. Biomed. Anal. 2019, 172, 9–17. DOI: 10.1016/j.jpba.2019.04.010.
  • Zezula, M.; Ruszczak, M.; Maruszak, W.; Zagrodzka, J.; Chodynski, M.; Dams, I. Dams, I. Development and Validation of the Stability Indicating RP-UHPLC Method for the Determination of the Chemical Purity and Assay of Bimatoprost. J. Pharm. Biomed. Anal. 2019, 174, 348–359. DOI: 10.1016/j.jpba.2019.06.002.
  • Sversut, R. A.; Vieira, J. C.; Kassab, N. M.; Silva, D. B.; Salgado, H. R. N. Forced Degradation Behavior of Two-Drug Combinations: Isolation and Characterization of Major Degradation Products by LC-MS. Microchem. J. 2019, 150, 104074. DOI: 10.1016/j.microc.2019.104074.
  • Ye, Q.; Huang, Y.; Grier, S.; Miller, S. A. Oxidative Degradation Pathways of Beclabuvir Hydrochloride Mediated by Hydrogen Peroxide and UV/VIS Light. J. Pharm. Biomed. Anal. 2019, 172, 388–394. DOI: 10.1016/j.jpba.2019.05.017.
  • Deng, Y.; Chen, X.; Wang, L.; Peng, X.; Lin, M. Characterization of Unknown Impurities in Coenzyme Q10 Using LC-MS and NMR. J. Pharm. Biomed. Anal. 2019, 175, 112771. DOI: 10.1016/j.jpba.2019.07.019.
  • Gad, M.; Hassan, S. A.; Zaazaa, H. E.; Amer, S. M. Multivariate Development and Optimization of Stability Indicating Method for Determination of Daclatasvir in Presence of Potential Degradation Products. Chromatographia. 2019, 82, 1641–1652. DOI: 10.1007/s10337-019-03793-y.
  • Deshpande, N.; Kamble, P.; Kulkarni, S.; Gawande, V. Optimized and Validated Stability Indicating RP-HPLC Method for Estimation of Nadolol. Pharm. Chem. J. 2019, 53, 1–9. DOI: 10.1007/s11094-020-02146-6.
  • Gu, X.; Chen, Y.; Lou, Y.; Zheng, J. Separation and Characterization of Forced Degradation Products in Homoharringtonine Injection by UHPLC-Q-TOF-MS. J. Pharm. Biomed. Anal. 2019, 176, 112801. DOI: 10.1016/j.jpba.2019.112801.
  • Saida, S. J.; Manikandan, A.; Kaliyaperumal, M.; Rumalla, C. S.; Khan, A. A.; Jayaraman, V. B.; Yanaka, R.; Rao, S. V. Identification, Isolation and Characterization of Dolutegravir Forced Degradation Products and Their Cytotoxicity Potential. J. Pharm. Biomed. Anal. 2019, 174, 588–594. DOI: 10.1016/j.jpba.2019.06.022.
  • Abd Elrahman, M. K.; Houssini, O. M. E.; Fahem, D. K.; Zaazaa, H. E. Stability Indicating Liquid Chromatography Method for the Analysis of Vecuronium Bromide: Study of the Degradation Profile. Heliyon. 2020, 6, e03530. DOI: 10.1016/j.heliyon.2020.e03530.
  • Hussein, L. A.; Magdy, N. N.; Ibrahim, M. A. Stability-Indicating RP-UPLC Method for Simultaneous Determination of Azilsartan Medoxomil and Chlorthalidone in Tablets in the Presence of Its Degradation Products. J. Chromatogr. Sci. 2019, 57, 213–219. DOI: 10.1093/chromsci/bmy102.
  • 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.
  • Xu, Q. Advancing USP Compendial Methods for Fixed Dose Combinations: A Case Study of Metoprolol Tartrate and Hydrochlorothiazide Tablets. J. Pharm. Anal. 2019, 9, 77–82. DOI: 10.1016/j.jpha.2018.12.003.
  • Fernandes, A. A Validated Stability Indicating RP-HPLC Method for Estimation of Tolfenamic Acid in Presence of Its Pharmacopoeial Impurities. Int. J. Appl. Biol. Pharm. 2019, 11, 264–270. DOI: 10.22159/ijap.2019v11i5.34606..
  • Dos Santos Moreira, C.; 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.
  • Carje, A. G.; Balint, A.; Ion, V.; Pop, A. L.; Muntean, D.-L.; Sabău, R.; Imre, S. HPLC-UV Method Approach for the Analysis and Impurity Profiling of Captopril. Stud. U. Babes-BolL. Che. 2019, 64, 231–242. DOI: 10.24193/subbchem.2019.2.19.
  • Palakeeti, B.; Ramesh, T.; Reddy, K. V.; Konakanchi, R.; Rao, P. N.; Gobi, K. V. Identification and Characterisation of Rucaparib Degradation Products and Their Comparison with Known Impurities. Chromatographia. 2019, 82, 591–604. DOI: 10.1007/s10337-018-3669-z.
  • Mallu, U. R.; Venkateswara Rao, A.; Kasimala, B. B. Rapid Stability Indicating HPLC Method for the Analysis of Leflunomide and Its Related Impurities in Bulk Drug and Formulations. Turk. J. Pharm. Sci. 2019, 16, 457–465. DOI: 10.4274/tjps.galenos.2018.34635.
  • Wang, J.; Zhou, J.; Xu, Y.; Zhu, B.; Jin, Y. Characterization of Two Unknown Impurities in Roxithromycin by 2D LC-QTOF/MS/MS and NMR. J. Pharm. Biomed. Anal. 2020, 184, 113196. DOI: 10.1016/j.jpba.2020.113196.
  • 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.
  • Li, Q.; Huang, Y.; Zhang, Y.; Cui, H.; Yin, L.; Li, Y.; Yuan, A.; Hu, Y.; Wu, J. A Novel HPLC Method for Analysis of Atosiban and Its Five Related Substances in Atosiban Acetate Injection. J. Pharm. Biomed. Anal. 2020, 177, 112808. DOI: 10.1016/j.jpba.2019.112808.
  • Liao, S.; Chen, H.; Wang, G.; Wu, S.; Yang, Z.; Luo, W.; Liu, Z.; Gao, X.; Qin, J.; Li, C-h.; Wang, Z. Identification, Characterization, Synthesis and Strategy for Minimization of Potential Impurities Observed in the Synthesis of Brivaracetam. Tetrahedron. 2020, 76, 131273. DOI: 10.1016/j.tet.2020.131273.
  • Liu, G.; Zhu, B.; Ren, X.; Wang, J. Characterization of 28 Unknown Impurities in 16-Membered Macrolides by Liquid Chromatography Coupled with Ion Trap/Time-Of-Flight Mass Spectrometry. J. Pharm. Biomed. Anal. 2020, 186, 113324. DOI: 10.1016/j.jpba.2020.113324.
  • Kurmi, M.; Sahu, A.; Balhara, A.; Singh, I. P.; Kulkarni, S.; Singh, N. K.; Garg, P.; Singh, S. Stability Behaviour of Antiretroviral Drugs and Their Combinations. 11: Characterization of Interaction Products of Zidovudine and Efavirenz, and Evaluation of Their anti HIV-1 Activity, and Physiochemical and ADMET Properties. J. Pharm. Biomed. Anal. 2020, 178, 112911. DOI: 10.1016/j.jpba.2019.112911.
  • Wang, C.; Dong, H.; Liu, H.; Sun, Z.; Yuan, A.; Wu, J.; Hu, Y. Using HPLC to Analyze (S)-Oxiracetam and Four Related Substances in the Bulk Drug of (S)-Oxiracetam. J. Pharm. Biomed. Anal. 2020, 180, 113072. DOI: 10.1016/j.jpba.2019.113072.
  • Christofi, M.; Markopoulou, C. K.; Tzanavaras, P. D.; Zacharis, C. K. UHPLC-Fluorescence Method for the Determination of Trace Levels of Hydrazine in Allopurinol and Its Formulations: Validation Using Total-Error Concept. J. Pharm. Biomed. Anal. 2020, 187, 113354. DOI: 10.1016/j.jpba.2020.113354.
  • Wu, P.; Li, M.; Kan, Y.; Wu, X.; Li, H. Impurities Identification and Quantification for Calcitonin Salmon by Liquid Chromatography-High Resolution Mass Spectrometry. J. Pharm. Biomed. Anal. 2020, 186, 113271. DOI: 10.1016/j.jpba.2020.113271.
  • Ruggenthaler, M.; Grass, J.; Schuh, W.; Huber, C. G.; Reischl, R. Impurity Profiling of liothyronine sodium by Means of Reversed Phase HPLC, High Resolution Mass Spectrometry, on-Line H/D Exchange and UV/VIS Absorption. J. Pharm. Biomed. Anal. 2017, 143, 147–158. DOI: 10.1016/j.jpba.2017.05.039.
  • Johnsirani, P.; Wani, A. A.; Bharatam, P. V.; Nanjappan, S. LC-ESI-QTOF-MS Analysis Utilizing Gas-Phase Fragmentation Reactions Subjected to ESI-IS-CID and ESI-CID-MS/MS Conditions to Study the Degradation Behaviour of Sorafenib Tosylate: NMR and in Vitro Cytotoxicity and Apoptosis Detection Studies of Hydrolytic Degradation Products. J. Pharm. Biomed. Anal. 2020, 177, 112881. DOI: 10.1016/j.jpba.2019.112881.
  • Singh, D. K.; Sahu, A.; Balhara, A.; Giri, S.; Singh, S. Insights into the Degradation Chemistry of Tazarotene, a Third Generation Acetylenic Retinoid: LC-HRMS (Orbitrap), LC-MSn and NMR Characterization of Its Degradation Products, and Prediction of Their Physicochemical and ADMET properties. J. Pharm. Biomed. Anal. 2020, 186, 113316. DOI: 10.1016/j.jpba.2020.113316.
  • Prajapati, K. J.; Kothari, C. S. First Report on Clorprenaline HCL Degradation Products: Identification and Characterization by LC–MS/MS. J. Iran. Chem. Soc. 2020, 17, 1027–1039. DOI: 10.1007/s13738-019-01831-y.
  • Chen, L.; Chen, J.; Lu, M.; Stämpfli, A. Simultaneous Determination of Elbasvir and Grazoprevir in Fixed-Dose Combination and Mass Spectral Characterization of Each Degradation Product by UHPLC-ESI-QTOF-MS/MS. J. Pharm. Biomed. Anal. 2020, 178, 112964. DOI: 10.1016/j.jpba.2019.112964.
  • Saraf, I.; Modhave, D.; Kushwah, V.; Neshchadin, D.; Gescheidt, G.; Trausinger, G.; Melchior, P.; Magnes, C.; Paudel, A. Feasibility of Rapidly Assessing Reactive Impurities Mediated Excipient Incompatibility Using a New Method: A Case Study of Famotidine-PEG System. J. Pharm. Biomed. Anal. 2020, 178, 112893. DOI: 10.1016/j.jpba.2019.112893.
  • Aleo, D.; Saita, M. G.; Spitaleri, F.; Sanfilippo, C.; Patti, A. Degradation Profile of Nepafenac in Aqueous Solution and Structural Characterization of a Novel Degradation Product. J. Pharm. Biomed. Anal. 2020, 189, 113432. DOI: 10.1016/j.jpba.2020.113432.
  • Gad, M. A.; Amer, S. M.; Zaazaa, H. E.; Hassan, S. A. Strategies for Stabilizing Formulation and QbD Assisted Development of Robust Stability Indicating Method of Azilsartan Medoxomil/Chlorthalidone. J. Pharm. Biomed. Anal. 2020, 178, 112910. DOI: 10.1016/j.jpba.2019.112910.
  • Jenkins, D.; Harmon, C. L.; Jia, X.; Kesselring, A.; Hatcher, D.; Grayson, K.; Ayres, J. Forced Degradation Studies of Medroxyprogesterone Acetate Injectable Suspensions (150 mg/ml) with implementation of HPLC, mass spectrometry, and QSAR techniques. J. Pharm. Biomed. Anal. 2020, 187, 113352. DOI: 10.1016/j.jpba.2020.113352.
  • Ragi, N. C.; Velma, G. R.; Pallerla, P. K.; Siddiqua, S.; Alugonda, V.; Rachamalla, H. K. R.; Pabbaraja, S.; Sripadi, P. Identification and Characterization of Forced Degradation Products of Vortioxetine by LC/MS/MS and NMR. J. Pharm. Biomed. Anal. 2020, 188, 113442. DOI: 10.1016/j.jpba.2020.113442.
  • Thalluri, B.; Dhiman, V.; Tiwari, S.; Baira, S. M.; Talluri, M. K. Study on Forced Degradation Behaviour of Dofetilide by LC-PDA and Q-TOF/MS/MS: Mechanistic Explanations of Hydrolytic, Oxidative and Photocatalytic Rearrangement of Degradation Products. J. Pharm. Biomed. Anal. 2020, 179, 112985. DOI: 10.1016/j.jpba.2019.112985.
  • Mital, N. P.; Charmy, K.; Vivek, V. An Innovative Impurity Profiling of Avanafil Using LC and LC-MS/MS with In-Silico Toxicity Prediction. Arab. J. Chem. 2020, 13, 6493–6509. DOI: 10.1016/j.arabjc.2020.06.007.
  • Douša, M.; Doubský, J.; Gajdošová, M.; Tkadlecová, M.; Martinů, T.; Jireš, J. Detection and Structure Elucidation of the New Degradation Impurities in the Pharmaceutical Formulations of Ruxolitinib Hydrobromide. J. Pharm. Biomed. Anal. 2020, 186, 113266. DOI: 10.1016/j.jpba.2020.113266.
  • Moura, F. C. S.; Dos Santos Machado, C. L.; Paula, F. R.; Couto, A. G.; Ricci, M.; Cechinel-Filho, V.; Bonomini, T. J.; Sandjo, L. P.; Bresolin, T. M. B. Taxifolin Stability: In Silico Prediction and In Vitro Degradation with HPLC-UV/UPLC-ESI-MS Monitoring . J. Pharm. Anal. 2021, 11, 232–240. DOI: 10.1016/j.jpha.2020.06.008.
  • Takyi-Williams, J.; Erasmus, L.; Hayeshi, R.; Grobler, A. Development and Validation of an LC-MS/MS Method for the Quantification of Goserelin in a Pheroid® Formulation, in Simulated Intestinal Fluid. J. Pharm. Biomed. Anal. 2020, 180, 113044. DOI: 10.1016/j.jpba.2019.113044.
  • Ganorkar, S. B.; Vander Heyden, Y.; Shirkhedkar, A. A.; Lokwani, D. K.; Dhumal, D. M.; Bobade, P. S. Pharmaceutical Analysis Combined with In-Silico Therapeutic and Toxicological Profiling on Zileuton and Its Impurities to Assist in Modern Drug Discovery. J. Pharm. Biomed. Anal. 2020, 179, 112982. DOI: 10.1016/j.jpba.2019.112982.
  • 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.
  • Tantawy, M. A.; Weshahy, S. A.; Wadie, M.; Rezk, M. R. Stability-Indicating HPTLC Method for the Simultaneous Detection and Quantification of Alfuzosin Hydrochloride, Solifenacin Succinate along with Four of Their Official Impurities. Microchem. J. 2020, 157, 104905. DOI: 10.1016/j.microc.2020.104905.
  • De Souza Barbosa, F.; Pezzi, L. C.; Tsao, M.; Macedo, S. M. D.; De Oliveira, T. F.; Schapoval, E. E.; Mendez, A. S. Stability in Clinical Use and Stress Testing of Meropenem Antibiotic by Direct Infusion ESI-Q-TOF: Quantitative Method and Identification of Degradation Products. J. Pharm. Biomed. Anal. 2020, 179, 112973. DOI: 10.1016/j.jpba.2019.112973.
  • Narenderan, S.; Ramesh, J.; Babu, B.; Meyyanathan, S. A Stability-Indicating LC-MS/MS Method Optimization for Pemetrexed Through Design of Experiments: Identification and Characterization of Major Oxidative Degradation Product. J. Pharm. Biomed. Anal. 2020, 183, 113150. DOI: 10.1016/j.jpba.2020.113150.
  • Tol, T.; Tawde, H.; Gorad, S.; Jagdale, A.; Kulkarni, A.; Kasbale, A.; Desai, A.; Samanta, G. Optimization of a Liquid Chromatography Method for the Analysis of Related Substances in Daclatasvir Tablets Using Design of Experiments Integrated with the Steepest Ascent Method and Monte Carlo Simulation. J. Pharm. Biomed. Anal. 2020, 178, 112943. DOI: 10.1016/j.jpba.2019.112943.
  • 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.
  • Chen, Y.; Li, H.; Hong, H.; Tao, H.; Peng, X.; Xu, G. Isolation and Characterization of Novel Process-Related Impurities in Empagliflozin. J. Pharm. Biomed. Anal. 2021, 198, 114001. DOI: 10.1016/j.jpba.2021.114001.
  • Guo, N.; He, Q.; Jin, Y.; Hou, Z.; Pan, Y.; Liu, J.; Sun, C. Separation and Characterization of Impurity P in Azithromycin Product. J. Pharm. Biomed. Anal. 2021, 195, 113853. DOI: 10.1016/j.jpba.2020.113853.
  • Luo, M.; Zheng, L.; Wang, S.; Zhu, J.; Tang, Z.; Gao, P. Characterization of Four Major Degradation Products in Metformin by 2D LC-QTOF/MS/MS. J. Pharm. Biomed. Anal. 2021, 192, 113662. DOI: 10.1016/j.jpba.2020.113662.
  • Mehta, L.; Naved, T.; Grover, P.; Bhardwaj, M.; Mukherjee, D. LC and LC-MS/MS Studies for Identification and Characterization of New Degradation Products of Ibrutinib and Elucidation of Their Degradation Pathway. J. Pharm. Biomed. Anal. 2021, 194, 113768. DOI: 10.1016/j.jpba.2020.113768.
  • Dhiman, V.; Balhara, A.; Singh, S.; Tiwari, S.; Gananadhamu, S.; Talluri, M. K. Characterization of Stress Degradation Products of Nintedanib by UPLC, UHPLC-Q-TOF/MS/MS and NMR: Evidence of a Degradation Product with a Structure Alert for Mutagenicity. J. Pharm. Biomed. Anal. 2021, 199, 114037. DOI: 10.1016/j.jpba.2021.114037.
  • Krait, S.; Wissenbach, D. K.; Peters, F. T.; Scriba, G. K. HPLC-MS Identification of Acid Degradation Products of Dolutegravir. J. Pharm. Biomed. Anal. 2021, 197, 113954. DOI: 10.1016/j.jpba.2021.113954.
  • Sahu, A. K.; Goswami, A.; Kate, A. S.; Sengupta, P. Identification and Structural Characterization of Potential Degraded Impurities of Ribociclib by Time of flight-tandem mass Spectrometry, and Their Toxicity Prediction . J. Pharm. Biomed. Anal. 2021, 197, 113933. DOI: 10.1016/j.jpba.2021.113933.
  • Jeelani, S.; Soukhova, N. Development and Validation of a Stability Indicating HPLC Method for Organic Impurities of Erythromycin Stearate Tablets. J. Pharm. Biomed. Anal. 2021, 195, 113858. DOI: 10.1016/j.jpba.2020.113858.
  • Han, X.; Cheng, F-j.; Di, B.; Xu, H.; Song, M.; Hang, T-j.; Lu, Y.-T. Identification and Characterization of New Impurities in Zopiclone Tablets by LC-QTOF-MS. J. Pharm. Biomed. Anal. 2021, 199, 114056. DOI: 10.1016/j.jpba.2021.114056.
  • Singh, S.; Handa, T.; Narayanam, M.; Sahu, A.; Junwal, M.; Shah, R. P. A Critical Review on the Use of Modern Sophisticated Hyphenated Tools in the Characterization of Impurities and Degradation Products. J. Pharm. Biomed. Anal. 2012, 69, 148–173. DOI: 10.1016/j.jpba.2012.03.044.
  • Imatani, K. Advances in Q-TOF LC/MS Systems for Pharma Applications. Available from: www.iptonline.com/articles/public/P30-32%20non-print.pdf. 2012.
  • Colson, K. L. Ultracool NMR Technology. Mod. Drug Discov. 2003, 47–51.
  • Kovacs, H.; Moskau, D.; Spraul, M. Cryogenically Cooled Probes-a Leap in NMR Technology. Prog. Nucl. Magn. Reson. Spectrosc. 2005, 46, 131–155. DOI: 10.1016/j.pnmrs.2005.03.001.
  • Cai, J.; Henion, J. Capillary Electrophoresis-Mass Spectrometry. J. Chromatogr. A. 1995, 703, 667–692. DOI: 10.1016/0021-9673(94)01178-H.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.