Ezetimibe: A Review of Analytical Methods for the Drug Substance, Pharmaceutical Formulations and Biological Matrices

References

• Wishart, D. S.; Feunang, Y. D.; Guo, A. C.; Lo, E. J.; Marcu, A.; Grant, J. R.; Sajed, T.; Johnson, D.; Li, C.; Sayeeda, Z.; et al. DrugBank 5.0: A Major Update to the DrugBank Database for 2018. Nucleic Acids Res 2017, Nov 8. DOI: 10.1093/nar/gkx1037.
   Google Scholar
• Nutescu, E. A.; Shapiro, N. L. Ezetimibe: A Selective Cholesterol Absorption Inhibitor. Pharmacotherapy 2003, 23, 1463–1474. DOI: 10.1592/phco.23.14.1463.31942.
   PubMed Web of Science ®Google Scholar
• Kosoglou, T.; Statkevich, P.; Johnson-Levonas, A.; Paolini, J. F.; Bergman, A. J.; Alton, K. B. Ezetimibe: A Review of Its Metabolism, Pharmacokinetics and Drug Interactions. Clin. Pharmacokinet. 2005, 44, 467–494. DOI: 10.2165/00003088-200544050-00002.
   PubMed Web of Science ®Google Scholar
• FDA Approved Drug Products: Zetia (ezetimibe) oral tablets. 2002.
   Google Scholar
• Niedzielski, M.; Broncel, M.; Gorzelak-Pabiś, P.; Woźniak, E. New Possible Pharmacological Targets for Statins and Ezetimibe. Biomed. Pharmacother. 2020, 129, 110388 DOI: 10.1016/j.biopha.2020.110388.
   PubMed Web of Science ®Google Scholar
• Mourikis, P.; Zako, S.; Dannenberg, L.; Nia, A. M.; Heinen, Y.; Busch, L.; Richter, H.; Hohlfeld, T.; Zeus, T.; Kelm, M.; Polzin, A. (2020). Lipid Lowering Therapy in Cardiovascular Disease: From Myth to Molecular reality. Pharmacol. Ther. 2020, 213, 107592 DOI: 10.1016/j.pharmthera.2020.107592.
   PubMed Web of Science ®Google Scholar
• Patel, J.; Sheehan, V.; Gurk-Turner, C. Ezetimibe (Zetia): a New Type of lipid-lowering agent. Proc (Bayl Univ Med Cent) 2003, 16, 354–358. DOI: 10.1080/08998280.2003.11927928.
   PubMedGoogle Scholar
• Dispas, A.; Avohou, H. T.; Lebrun, P.; Hubert, P.; Hubert, C. Quality by Design’ Approach for the Analysis of Impurities in Pharmaceutical Drug Products and Drug Substances. Trend Anal. Chem. 2018, 101, 24–33. DOI: 10.1016/j.trac.2017.10.028.
   Web of Science ®Google Scholar
• Holm, R.; Elder, D. P. Analytical Advances in Pharmaceutical Impurity Profiling. Eur. J. Pharm. Sci. 2016, 87, 118–135. DOI: 10.1016/j.ejps.2015.12.007.
   PubMed Web of Science ®Google Scholar
• Kątny, M.; Frankowski, M. Impurities in Drug Products and Active Pharmaceutical Ingredients. Crit. Rev. Anal. Chem. 2017, 47, 187–193. DOI: 10.1080/10408347.2016.1242401.
   PubMed Web of Science ®Google Scholar
• Ramachandra, B. Development of Impurity Profiling Methods Using Modern Analytical Techniques. Crit. Rev. Anal. Chem. 2017, 47, 24–36. DOI: 10.1080/10408347.2016.1169913.
   PubMed Web of Science ®Google Scholar
• Olsen, B. A.; Sreedhara, A.; Baertschi, S. W. Impurity Investigations by Phases of Drug and Product Development. Trend Anal. Chem. 2018, 101, 17–23. DOI: 10.1016/j.trac.2017.10.025.
   Web of Science ®Google Scholar
• Görög, S. Critical Review of Reports on Impurity and Degradation Product Profiling in the Last Decade. Trend Anal. Chem. 2018, 101, 2–16. DOI: 10.1016/j.trac.2017.09.012.
   Web of Science ®Google Scholar
• ICH Guideline, Stability Testing of New Drug Substances and Products Q1A (R2). Geneva, Switzerland, IFPMA, 2003.
   Google Scholar
• ICH Guideline, Impurities in New Drug Substances Q3A (R2). IFPMA, Geneva, Switzerland, 2006.
   Google Scholar
• ICH Guideline, Impurities in New Drug Products Q3B (R2). IFPMA, Geneva, Switzerland, 2006.
   Google Scholar
• ICH M10, Bioanalytical method validation draft guideline. IFPMA, Geneva, Switzerland, 2019.
   Google Scholar
• Panuwet, P.; Hunter, R. E.; Jr, D'Souza, P. E.; Chen, X.; Radford, S. A.; Cohen, J. R.; Marder, M. E.; Kartavenka, K.; Ryan, P. B.; Barr, D. B. Biological Matrix Effects in Quantitative Tandem Mass Spectrometry-Based Analytical Methods: Advancing Biomonitoring. Crit. Rev. Anal. Chem. 2016, 46, 93–105. DOI: 10.1080/10408347.2014.980775.
   PubMed Web of Science ®Google Scholar
• USP 45. The United States Pharmacopeia 2020.
   Google Scholar
• Clader, J. W. The Discovery of Ezetimibe: A View from outside the Receptor. J. Med. Chem. 2004, 47, 1–9. DOI: 10.1021/jm030283g.
   PubMed Web of Science ®Google Scholar
• Galletti, P.; Giacomini, D. Monocyclic β-Lactams: new Structures for New Biological Activities. Curr. Med. Chem. 2011, 18, 4265–4283. DOI: 10.2174/092986711797200480.
   PubMed Web of Science ®Google Scholar
• Mehta, P. D.; Sengar, N. P. S.; Pathak, A. K. 2-Azetidinone – a New Profile of Various Pharmacological Activities. Eur. J. Med. Chem. 2010, 45, 5541–5560. DOI: 10.1016/j.ejmech.2010.09.035.
   PubMed Web of Science ®Google Scholar
• Burnett, D. Beta-lactam Cholesterol Absorption Inhibitors . Curr. Med. Chem. 2004, 11, 1873–1887. DOI: 10.2174/0929867043364865.
   PubMed Web of Science ®Google Scholar
• Arya, N.; Jagdale, A. Y.; Patil, T. A.; Yeramwar, S. S.; Holikatti, S. S.; Dwivedi, J.; Shishoo, C. J.; Jain, K. S. The Chemistry and Biological Potential of Azetidin-2-Ones. Eur. J. Med. Chem. 2014, 74, 619–656. DOI: 10.1016/j.ejmech.2014.01.002.
   PubMed Web of Science ®Google Scholar
• National Center for Biotechnology Information. PubChem Database. Ezetimibe, CID = 150311. https://pubchem.ncbi.nlm.nih.gov/compound/Ezetimibe (accessed Apr 22, 2020).
   Google Scholar
• Atici, E. B.; Karlığa, B. Identification, Synthesis and Characterization of process related Desfluoro Impurity of Ezetimibe and HPLC Method Validations . J. Pharm. Anal. 2015, 5, 356–370. DOI: 10.1016/j.jpha.2015.04.002.
   PubMedGoogle Scholar
• Earl, J.; Kirkpatrick, P. Fresh from the pipeline. Ezetimibe. Nat. Rev. Drug Discov. 2003, 2, 97–98. DOI: 10.1038/nrd1015.
   PubMedGoogle Scholar
• Rosenblum, S. B.; Huynh, T.; Afonso, A.; Davis, H. R.; Yumibe, N.; Clader, J. W.; Burnett, D. A. Discovery of 1-(4-fluorophenyl)-(3R)-[3-(4-fluorophenyl)-(3S)-hydroxypropyl]-(4S)-(4 -hydroxyphenyl)-2-Azetidinone (SCH 58235): A Designed, Potent, Orally Active Inhibitor of Cholesterol Absorption . J. Med. Chem. 1998, 41, 973–980. DOI: 10.1021/jm970701f.
   PubMed Web of Science ®Google Scholar
• Torrado-Salmerón, C.; Guarnizo-Herrero, V.; Gallego-Arranz, T.; del Val-Sabugo, Y.; Torrado, G.; Morales, J.; Torrado-Santiago, S. Improvement in the Oral Bioavailability and Efficacy of New Ezetimibe Formulations—Comparative Study of a Solid Dispersion and Different Micellar Systems. Pharmaceutics 2020, 12, 617. DOI: 10.3390/pharmaceutics12070617.
   PubMed Web of Science ®Google Scholar
• Shukr, M. H.; Ismail, S.; Ahmed, S. M. Development and Optimization of Ezetimibe Nanoparticles with Improved Antihyperlipidemic Activity. J. Drug Deliv. Sci. Technol. 2019, 49, 383–395. DOI: 10.1016/j.jddst.2018.12.001.
   Web of Science ®Google Scholar
• Davidson, M. H.; McGarry, T.; Bettis, R.; Melani, L.; Lipka, L. J.; LeBeaut, A. P.; Suresh, R.; Sun, S.; Veltri, E. P. Ezetimibe Study Group. Ezetimibe Coadministered with Simvastatin in Patients with Primary Hypercholesterolemia. J. Am. Coll. Cardiol. 2002, 40, 2125–2134. DOI: 10.1016/S0735-1097(02)02610-4.
   PubMed Web of Science ®Google Scholar
• Kosoglou, T.; Meyer, I.; Veltri, E. P.; Statkevich, P.; Yang, B.; Zhu, Y.; Mellars, L.; Maxwell, S. E.; Patrick, J. E.; Cutler, D. L.; et al. (2002). Pharmacodynamic Interaction Between the New Selective Cholesterol Absorption Inhibitor Ezetimibe and Simvastatin. Br. J. Clin. Pharmacol. 2002, 54, 309–319. DOI: 10.1046/j.1365-2125.2002.01633.x.
   PubMed Web of Science ®Google Scholar
• Knopp, R. H.; Gitter, H.; Truitt, T.; Bays, H.; Manion, C. V.; Lipka, L. J.; LeBeaut, A. P.; Suresh, R.; Yang, B.; Veltri, E. P. Effects of Ezetimibe, a New Cholesterol Absorption Inhibitor, on Plasma Lipids in Patients with Primary Hypercholesterolemia. Eur. Heart J. 2003, 24, 729–741. DOI: 10.1016/S0195-668X(02)00807-2.
   PubMed Web of Science ®Google Scholar
• Soulele, K.; Karalis, V. Development of a Joint Population Pharmacokinetic Model of Ezetimibe and Its Conjugated Metabolite. Eur. J. Pharm. Sci. 2019, 128, 18–26. DOI: 10.1016/j.ejps.2018.11.018.
   PubMed Web of Science ®Google Scholar
• Lestari, M. L.; Ardiana, F.; Indrayanto, G. Ezetimibe. In Profiles Drug Subst Excip Relat Methodol 2011, 36, 103–149. Academic Press. DOI: 10.1016/B978-0-12-387667-6.00016-6.
   PubMedGoogle Scholar
• El-Moghazy, S. M.; Mohamed, M. A. E.-A.; Mohamed, M. F.; Youssef, N. F. Development and Validation of HPLC, TLC and Derivative Spectrophotometric Methods for the Analysis of Ezetimibe in the Presence of Alkaline Induced Degradation Products. J. Chinese Chemical Soc. 2009, 56, 360–367. DOI: 10.1002/jccs.200900052.
   Web of Science ®Google Scholar
• Oliveira, P. R.; Junior, L. B.; Fronza, M.; Bernardi, L. S.; Masiero, S. M. K.; Dalmora, S. L. Development and Validation of a Liquid Chromatography-Tandem Mass Spectrometry Method for the Determination of Ezetimibe in Human Plasma and Pharmaceutical Formulations. Chroma. 2006, 63, 315–320. DOI: 10.1365/s10337-006-0749-2.
   Web of Science ®Google Scholar
• Panjwani, G.; Shetty, R.; Shenoy, G.; Dhamecha, D. Development and Validation of a New Reversed-Phase HPLC Method for the Determination of Ezetimibe in Pharmaceutical Dosage Forms. Indian J. Pharm. Educ. 2013, 47, 7–12.
   Google Scholar
• Kumar, P.; Ahmad, Y.; Ghosh, A. A Stability-Indicating RP-HPLC Method Development for Determination of Ezetimibe in Tablet Dosage Form. Der Pharma Chem. 2012, 4, 1296–1304.
   Google Scholar
• Sistla, R.; Tata, V. S. S. K.; Kashyap, Y. V.; Chandrasekar, D.; Diwan, P. V. Development and Validation of a Reversed-Phase HPLC Method for the Determination of Ezetimibe in Pharmaceutical Dosage Forms. J. Pharm. Biomed. Anal. 2005, 39, 517–522. DOI: 10.1016/j.jpba.2005.04.026.
   PubMed Web of Science ®Google Scholar
• Doshi, A. S.; Kachhadia, P. K.; Joshi, H. S. Validation of a Stability-Indicating LC Method for Assay of Ezetimibe in Tablets and for Determination of Content Uniformity. Chroma. 2008, 67, 137–142. DOI: 10.1365/s10337-007-0470-9.
   Web of Science ®Google Scholar
• Baokar Shrikrishna, B.; Erande, R.; Shaikh, S. Analytical Method Development and Validation for Estimation of Ezetimibe from Tablet Dosage Form by Using RP-HPLC. Int. J. Res. Pharm. Biomed. Sci. 2011, 2, 833–841.
   Google Scholar
• Danafar, H.; Hamidi, M. A Rapid and Sensitive LC–MS Method for Determination of Ezetimibe Concentration in Human Plasma: application to a Bioequivalence Study. Chromatographia 2013, 76, 1667–1675. DOI: 10.1007/s10337-013-2548-x.
   Web of Science ®Google Scholar
• Krishna, M. R.; Kumar, S. P.; Khurdhus, M. S. K.; Vaishnavi, G.; Mamatha, M.; Ravi, K. A Rapid Determination of Ezetimibe in Bulk and Pharmaceutical Formulations by Using RP-HPLC. World J. Pharm. Pharm. Sci. 2017, 6, 971–978. DOI: 10.20959/wjpps20177-9475.
   Google Scholar
• Bhagwat, A. M.; Khadke, A. P.; Patil, A. M.; Sawakhande, S. N.; Kulkarni, R. J.; Tarade, S. V. Development and Validation of Novel UV Spectroscopic Assay Method of Ezetimibe in Bulk Drugs and Drug Formulations. World J. Pharm. Res. 2017, 6, 507–517. DOI: 10.20959/wjpr20174-8137.
   Google Scholar
• Shrivastava, P. K.; Basniwal, P. K.; Shrivastava, S. K.; Jain, D. Validated RP-HPLC Method for Estimation of Ezetimibe in Different Tablet Dosage Form. Int. J. Phy. Sci. 2009, 1, 174–181.
   Google Scholar
• Akmar, S. K.; Kothapalli, L.; Thomas, A.; Jangam, S. Reverse Phase High Performance Liquid Chromatography Method for Estimation of Ezetimibe in Bulk and Pharmaceutical Formulations. Indian J. Pharm. Sci. 2007, 69, 695–697.
   Google Scholar
• Bahrami, G.; Mohammadi, B.; Khatabi, P. M.; Farzaei, M. H.; Majnooni, M. B.; Bahoosh, S. R. Application of One-step Liquid Chromatography-electrospray Tandem MS/MS and Collision-Induced Dissociation to Quantification of Ezetimibe and Identification of Its Glucuronated Metabolite in Human Serum: A Pharmacokinetic Study . J Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2010, 878, 2789–2795. DOI: 10.1016/j.jchromb.2010.08.023.
   PubMed Web of Science ®Google Scholar
• Bae, J.-W.; Choi, C.-I.; Park, S.-H.; Jang, C.-G.; Lee, S.-Y. Analytical LC-MS/MS Method for Ezetimibe and Its Application for Pharmacokinetic Study. J. Liq. Chromatogr. Rel. Technol. 2012, 35, 141–152. DOI: 10.1080/10826076.2011.597065.
   Web of Science ®Google Scholar
• Suchy, D.; Łabuzek, K.; Pierzchała, O.; Okopień, B. RP-HPLC-UV Determination of Ezetimibe in Serum: Method Development, Validation and Application to Patients Chronically Receiving the Drug. Acta Chromatogr. 2013, 25, 483–502. DOI: 10.1556/AChrom.25.2013.3.6.
   Web of Science ®Google Scholar
• Li, S.; Liu, G.; Jia, J.; Li, X.; Yu, C. Liquid Chromatography-negative Ion Electrospray Tandem Mass Spectrometry Method for the Quantification of Ezetimibe in Human Plasma. J. Pharm. Biomed. Anal. 2006, 40, 987–992. DOI: 10.1016/j.jpba.2005.07.053.
   PubMed Web of Science ®Google Scholar
• Babu, M. S.; Kumar, V. R.; Reddy, B. P. B.; Rao, V. S.; Sharma, H. K. Development and Validation of a High-Throughput LC–MS/MS Method for the Quantitation of Total Ezetimibe in Human Plasma. Int. J. Pharm. Sci. Rev. Res. 2016, 39, 338–345.
   Google Scholar
• Park, Y. S.; Kim, D. P.; Kang, S. H.; Kim, K. T.; Hwan, Y.; Hoon, J.; Na, Y.; Young, J.; Sim, S. J.; Jin, B. R.; Lee, H. S. Development and Validation of Simple and Rapid LC-MS/MS Method for Ezetimibe in Human Plasma and Its Application to Bioequivalence Study. IOSR J. Pharm. Biol. Sci. 2017, 12, 01–08. DOI: 10.9790/3008-1204070108.
   Google Scholar
• Guo, L.; Wang, M. M.; He, M.; Qiu, F. R.; Jiang, J. Simultaneous Determination of Ezetimibe and Its Glucuronide Metabolite in Human Plasma by Solid Phase Extraction and Liquid Chromatography–Tandem Mass Spectrometry. J. Chromatogr. B 2015, 986, 108–114. DOI: 10.1016/j.jchromb.2015.02.012.
   PubMed Web of Science ®Google Scholar
• Di, M.; Li, Z.; Jiang, Q.; Wang, T.; Zhang, W.; Sun, Z.; Sun, J.; Liu, X. A Rapid and Sensitive Supercritical Fluid Chromatography/Tandem Mass Spectrometry Method for Detection of Ezetimibein Dog Plasma and Its Application in Pharmacokinetic Studies. J. Chromatogr. B Analyt Technol. Biomed. Life Sci. 2018, 1073, 177–182. DOI: 10.1016/j.jchromb.2017.10.053.
   PubMed Web of Science ®Google Scholar
• Raman, B.; Sharma, B. A.; Butala, R.; Ghugare, P. D.; Kumar, A. Structural Elucidation of a Process-Related Impurity in Ezetimibe by LC/MS/MS and NMR. J. Pharm. Biomed. Anal. 2010, 52, 73–78. DOI: 10.1016/j.jpba.2009.12.021.
   PubMed Web of Science ®Google Scholar
• Filip, K.; Bańkowski, K.; Sidoryk, K.; Zagrodzka, J.; Łaszcz, M.; Trzcińska, K.; Szyprowska, A.; Cmoch, P.; Maruszak, W. Physicochemical Characterization of Ezetimibe and Its Impurities. J. Mol. Struct 2011, 991, 162–170. DOI: 10.1016/j.molstruc.2011.02.020.
   Web of Science ®Google Scholar
• Guntupalli, S.; Ray, U. K.; Murali, N.; Gupta, P. B.; Kumar, V. J.; Satheesh, D.; Islam, A. Identification, Isolation and Characterization of Process Related Impurities in Ezetimibe. J. Pharm. Biomed. Anal. 2014, 88, 385–390. DOI: 10.1016/j.jpba.2013.09.020.
   PubMed Web of Science ®Google Scholar
• Zhang, D.; Su, J. Investigation of Reduction Process and Related Impurities in Ezetimibe. J. Pharm. Biomed. Anal. 2015, 107, 355–363. DOI: 10.1016/j.jpba.2015.01.008.
   PubMed Web of Science ®Google Scholar
• Luo, Z.; Deng, Z.; Liu, Y.; Wang, G.; Yang, W.; Hou, C.; Tang, M.; Yang, R.; Zhou, H. Development and Validation of a Novel Stability-Indicating HPLC Method for the Quantitative Determination of Eleven Related Substances in Ezetimibe Drug Substance and Drug Product. Talanta 2015, 139, 67–74. DOI: 10.1016/j.talanta.2015.02.039.
   PubMed Web of Science ®Google Scholar
• Balasubramanian, H.; Kumar, R. S.; Anireddy, J. S.; Rao, D. V. Development of a Simple, Highly Selective RP-LC Method for the Quantification of Diastereomers and Other Related Substances of Ezetimibe Using Multivariate Analysis. J. Chromatogr. Sci. 2019, 57, 71–80. DOI: 10.1093/chromsci/bmy084.
   PubMed Web of Science ®Google Scholar
• Sun, L.; Zou, Q.; Wei, P.; Ouyang, P. Chiral Separation and Thermodynamic Investigation of Ezetimibe Optical Isomers on a Chiralpak IC Column. J. Chromatogr. Sci. 2016, 54, 1489–1494. DOI: 10.1093/chromsci/bmw032.
   PubMed Web of Science ®Google Scholar
• Chimalakonda, K. R.; Gudala, V.; Gutta, M.; Polisetty, S.; Koduri, S. V. S. Development and Validation of Chiral HPLC Method for Identification and Quantification of (R)-Enantiomer in Ezetimibe. AJAC. 2012, 03, 478–483. DOI: 10.4236/ajac.2012.37063.
   Google Scholar
• Chimalakonda, K.; Kamani, V.; Gutta, M.; Polisetty, S.; Koduri, S. V. S. Isolation and Characterization of R-Enantiomer in Ezetimibe. AJAC. 2013, 04, 488–495. DOI: 10.4236/ajac.2013.49062.
   Google Scholar
• Zhu, B.; Yao, Y.; Zhao, Y.; Sun, T.; Li, Q. Study on the HPLC-based Separation of Some Ezetimibe Stereoisomers and the Underlying Stereorecognition Process. Chirality 2018, 30, 642–651. DOI: 10.1002/chir.22829.
   PubMed Web of Science ®Google Scholar
• Jagu, P.; Baksam, V. K.; Rao, B. M.; Nittala, S. R. A Novel Enantio-Selective Reverse Phase HPLC Method for the Determination of Ezetimibe and It's Enantiomer. World J. Pharm. Res. 2015, 4, 1605–1619.
   Google Scholar
• Barhate, C. L.; Breitbach, Z. S.; Pinto, E. C.; Regalado, E. L.; Welch, C. J.; Armstrong, D. W. Ultrafast Separation of Fluorinated and Desfluorinated Pharmaceuticals Using Highly Efficient and Selective Chiral Selectors Bonded to Superficially Porous Particles. J. Chromatogr. A. 2015, 1426, 241–247. DOI: 10.1016/j.chroma.2015.11.056.
   PubMed Web of Science ®Google Scholar
• Regalado, E. L.; Dermenjian, R. K.; Joyce, L. A.; Welch, C. J. Detection of Dehalogenation Impurities in Organohalogenated Pharmaceuticals by UHPLC-DAD-HRESIMS. J. Pharm. Biomed. Anal. 2014, 92, 1–5. DOI: 10.1016/j.jpba.2013.12.043.
   PubMed Web of Science ®Google Scholar
• Dong, S.; Yang, H.; Ye, D. Development of an LC-MS Method for 4-Fluoroaniline Determination in Ezetimibe. J. Chromatogr. Sci. 2018, 56, 724–730. DOI: 10.1093/chromsci/bmy048.
   Google Scholar
• Mannam, M. R.; Sankareswaran, S.; Gaddam, V. R.; Natarajan, S.; Kottapalli, R. P.; Kumar, P. Structural Correction and Process Improvement for Control of a Critical Process Impurity of Ezetimibe. Org. Process. Res. Dev. 2019, 23, 919–925. DOI: 10.1021/acs.oprd.9b00024.
   Google Scholar
• Kancherla, P.; Velpuri, V.; Alegete, P.; Albaseer, S. S.; Khagga, M.; Das, P. LC–MS/MS Characterization of the Forced Degradation Products of Ezetemibe: Development and Validation of a Stability-Indicating UPLC Method. J. Taibah Univ. Sci. 2016, 10, 148–160. DOI: 10.1016/j.jtusci.2015.08.001.
   Web of Science ®Google Scholar
• Singh, S.; Singh, B.; Bahuguna, R.; Wadhwa, L.; Saxena, R. Stress Degradation Studies on Ezetimibe and Development of a Validated Stability-Indicating HPLC Assay. J. Pharm. Biomed. Anal. 2006, 41, 1037–1040. DOI: 10.1016/j.jpba.2006.01.030.
   PubMed Web of Science ®Google Scholar
• Gajjar, A. K.; Shah, V. D. Impurity Profiling: A Case Study of Ezetimibe. Open Conf. Proc. J. 2011, 2, 108–112. DOI: 10.2174/2210289201102010108.
   Google Scholar
• Gajjar, A. K.; Shah, V. D. Isolation and Structure Elucidation of Major Alkaline Degradant of Ezetimibe. J. Pharm. Biomed. Anal. 2011, 55, 225–229. DOI: 10.1016/j.jpba.2010.12.033.
   PubMed Web of Science ®Google Scholar
• Baťová, J.; Imramovský, A.; HájÍček, J.; Hejtmánková, L.; Hanusek, J. Kinetics and Mechanism of the Base-Catalyzed Rearrangement and Hydrolysis of Ezetimibe. J. Pharm. Sci. 2014, 103, 2240–2247. DOI: 10.1002/jps.24070.
   PubMed Web of Science ®Google Scholar
• Jin, J.; Wang, Z.; Lin, J.; Zhu, W.; Gu, C.; Li, M. "Ghost peaks" of Ezetimibe: Solution Degradation Products of Ezetimibe in Acetonitrile Induced by Alkaline Impurities from Glass HPLC Vials” . J. Pharm. Biomed. Anal. 2017, 140, 281–286. DOI: 10.1016/j.jpba.2017.02.059.
   PubMed Web of Science ®Google Scholar
• Alarfaj, N. A.; Aly, F. A. Micelle-Enhanced Spectrofluorimetric Method for Determination of Cholesterol-Reducing Drug Ezetimibe in Dosage Forms. J. Fluoresc. 2012, 22, 9–15. DOI: 10.1007/s10895-011-0952-x.
   PubMed Web of Science ®Google Scholar
• Gupta, K.; Singhvi, I. Development of UV Spectrophotometric Method for the Estimation of Ezetimibe from Tablet Formulation. Int. J. Chem. Sci. 2015, 13, 1051–1056.
   Google Scholar
• Kabra, R. P.; Kadam, S. C.; Mane, V. B.; Kadam, S. S.; Mamde, C. G. Simple Novel UV-Spectroscopic Method for Estimation of Ezetimibe in Tablet Dosage Form. Am. J. Pharm. Health Res. 2014, 2, 66–71.
   Google Scholar
• Lakshmi, P.; Ramchandran, D.; Rambabu, C. Spectrophotometric Determination of Ezetimibe. J. Chem. 2010, 7, 101–104. DOI: 10.1155/2010/238140.
   Web of Science ®Google Scholar
• Baraka, M. M.; Khalil, H. M.; Al-Ahmary, K. M. Colorimetric Determination of Ezetimibe in Pure Form and in Pharmaceutical Preparation. Bull. Fac. Pharm.(Cairo Univ.) 2008, 46, 163–167.
   Google Scholar
• Narasimharaju, B. C.; Devalarao, G.; Ramanjaneyulu, S. Spectrophotometric Method for the Determination of Ezetimibe in Pharmaceutical Formulations. Biomed. Pharmacol. J. 2008, 1, 413–416.
   Google Scholar
• Sharma, M.; Mhaske, D. V.; Mahadik, M.; Kadam, S. S.; Dhaneshwar, S. R. UV and Three Derivative Spectrophotometric Methods for Determination of Ezetimibe in Tablet Formulation. Indian J. Pharm. Sci. 2008, 70, 258–260. DOI: 10.4103/0250-474X.41471.
   PubMed Web of Science ®Google Scholar
• Dalmora, S. L.; Oliveira, P. R.; Barth, T.; Todeschini, V. Development and Validation of a Stability-Indicating Micellar Electrokinetic Chromatography Method for the Determination of Ezetimibe in Pharmaceutical Formulations. Anal. Sci. 2008, 24, 499–503. DOI: 10.2116/analsci.24.499.
   PubMed Web of Science ®Google Scholar
• Uçaktürk, E.; Özaltin, N.; Kaya, B. Quantitative Analysis of Ezetimibe in Human Plasma by Gas Chromatography-Mass Spectrometry. J. Sep. Sci. 2009, 32, 1868–1874. DOI: 10.1002/jssc.200900078.
   PubMed Web of Science ®Google Scholar
• Mahadik, M.; Dhaneshwar, S. Application of a Stability-Indicating HPTLC Method for the Quantitative Determination of Ezetimibe in Pharmaceutical Dosage Forms. Asian J. Pharm. Sci. 2007, 2, 182–190. DOI: 10.5138/ijaps.2010.0976.1055.01048.
   Google Scholar
• Uçaktürk, E.; Özaltin, N. Optimization of a Gas Chromatography–Mass Spectrometry Method Using Chemometric Techniques for the Determination of Ezetimibe in Human Plasma. Turk. J. Chem. 2013, 37, 734– 745. DOI: 10.3906/kim-1210-18.
   Web of Science ®Google Scholar
• Abdelfattah, A.; Elabasawi, N.; Abo-Serie, A.; Attia, K.; Morshedy, S. Densitometric Determination of Ezetimibe in the Presence of Its Alkaline Degradation Product. J. Adv.Pharm. Res. 2018, 2, 212–220.
   Google Scholar
• Chitravathi, S.; Reddy, S.; Swamy, B. K. (2016). Electrochemical Determination of Ezetimibe by MgO Nanoflakes-Modified Carbon Paste Electrode. J. Electroanal. Chem. 2016, 764, 1–6. DOI: 10.1016/j.jelechem.2016.01.001.
   Web of Science ®Google Scholar
• Ren, Y.; Duan, Y. J.; Li, R. J.; Deng, Y.; Hai, L.; Wu, Y. First Synthesis and Characterization of Key Stereoisomers Related to Ezetimibe. Chin. Chem. Lett. 2014, 25, 1157–1160. DOI: 10.1016/j.cclet.2014.03.035.
   Web of Science ®Google Scholar