Chromatographic determination of clopidogrel bisulfate; detection and quantification of counterfeit Plavix® tablets

Bulletin of Faculty of Pharmacy, Cairo University - Tập 52 - Trang 91-101 - 2014
Mona E. ElTantawy1, Lories I. Bebawy1, Rafeek F. Shokry1
1National Organization for Drug Control and Research (NODCAR), 51 Wezaret El-Zeraa St., Dokki, Cairo, Egypt

Tài liệu tham khảo

Ulrike, 2011, Analytical challenges in drug counterfeiting and falsification – the NMR approach, J Pharm Biomed Anal, 55, 679, 10.1016/j.jpba.2010.12.017 Preliminary Draft Survey On National Legislation On “Counterfeit Medicines” WHO; 2010. Medicines: spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines WHO (http://www.who.int/mediacenter/factsheets/fs275) 2012. Burki, 2010, The real cost of counterfeit medicines, Lancet Infect Dis, 10, 585, 10.1016/S1473-3099(10)70173-0 Laurence Brunton L. Goodman & Gilman’s: the pharmacological basis of therapeutics. 12th ed., USA: McGraw-Hill Professional; 2011. Tripathi, 2004 Satoskar, 1997 Budavari, 2006 Mitakos, 2004, Determination of the carboxylic acid metabolite of clopidogrel in human plasma by liquid chromatography–electrospray ionization mass spectrometry, Anal Chim Acta, 505, 107, 10.1016/S0003-2670(03)00019-9 Ksycińska, 2006, Determination of clopidogrel metabolite (SR26334) in human plasma by LC-MS, J Pharm Biomed Anal, 41, 533, 10.1016/j.jpba.2005.11.035 Grenier, 2003, The single-dose pharmacokinetics of clopidogrel in healthy adult volunteers, Clin Pharmacol Ther, 73, 47 Taubert, 2004, Pharmacokinetics of clopidogrel after administration of a high loading dose, Thromb Haemost, 92, 311, 10.1160/TH04-02-0105 Lainesse, 2004, Bioequivalence study of clopidogrel bisulfate film-coated tablets, Arzneim–Forsch/Drug Res, 54, 600 Lagorce, 1998, Assay method for the carboxylic acid metabolite of clopidogrel in human plasma by gas chromatography-mass spectrometry, J Chromatogr B, 720, 107, 10.1016/S0378-4347(98)00452-6 Mitakos, 2002, A validated LC method for the determination of clopidogrel in pharmaceutical preparations, J Pharm Biomed Anal, 28, 431, 10.1016/S0731-7085(01)00620-3 Aboul-Enein, 2005, Reversed phase liquid chromatographic method for the high-throughput analysis of clopidogrel in pharmaceutical formulations using a monolithic silica column, J Liq Chromatogr Relat Techno, 28, 1357, 10.1081/JLC-200054835 Gomez, 2004, Analysis of purity in 19 drug product tablets containing clopidogrel: 18 copies versus the original brand, J Pharm Biomed Anal, 34, 341, 10.1016/S0731-7085(03)00533-8 Antic, 2007, A simple and sensitive TLC method for determination of clopidogrel and its impurity SR 26334 in pharmaceutical products, Acta Chromatogr, 18, 199 Kalyanaraman, 2010, A validated stability-indicating normal phase LC method for clopidogrel bisulfate and its impurities in bulk drug and pharmaceutical dosage form, J Pharm Biomed Anal, 52, 1160 Belal, 2009, Stability-indicating micellar liquid chromatographic method for the determination of clopidogrel. Application to tablets and content uniformity testing, J Liq Chromatogr Relat Technol, 32, 2993, 10.1080/10826070903320764 Hala Zaazaa, 2009, Spectrophotometric and spectrodensitometric determination of Clopidogrel Bisulfate with kinetic study of its alkaline degradation, Talanta, 78, 874, 10.1016/j.talanta.2008.12.064 Agrawal, 2003, Stability indicating HPTLC determination of clopidogrel bisulphate as bulk drug and in pharmaceutical dosage form, Talanta, 61, 581, 10.1016/S0039-9140(03)00364-3 Londhe, 2011, Development and validation of a reversed-phase HPLC method for simultaneous determination of aspirin, atorvastatin calcium and clopidogrel bisulphate in capsules, Indian J Pharm Sci, 73, 23, 10.4103/0250-474X.89753 Kachhadia Pankaj, 2009, Validated column high-performance liquid chromatographic method for determination of aspirin and clopidogrel in combined tablets in the presence of degradation products formed under ICH recommended stress conditions, J AOAC Int, 92, 152, 10.1093/jaoac/92.1.152 Anandakumar, 2007, RP-HPLC analysis of aspirin and clopidogrel bisulphate in combination, Indian J Pharm Sci, 69, 597, 10.4103/0250-474X.36958 Gandhimathi, 2007, High performance liquid chromatographic determination of aspirin and clopidogrel in tablets, Indian J Pharm Sci, 69, 123, 10.4103/0250-474X.32125 Shrivastava, 2008, Concurrent estimation of clopidogrel bisulfate and aspirin in tablets by validated RP-HPLC method, Indian J Pharm Sci, 70, 667, 10.4103/0250-474X.45414 Purushotam, 2009, A validated stability indicating HPTLC method for determination of aspirin and clopidogrel bisulfate in combined dosage form, Eurasian J Anal Chem, 4, 152 Mishra, 2006, Simultaneous determination of clopidogrel and aspirin in pharmaceutical dosage forms, Indian J Pharm Sci, 68, 365, 10.4103/0250-474X.26682 Rajput, 2008, Chemometric simultaneous estimation of clopidogrel bisulphate and aspirin from combined dosage form, Indian J Pharm Sci, 70, 450, 10.4103/0250-474X.44592 http://www.who.int/medicines/services/counterfeit/overview/en/index.html. The United States Pharmacopeia and National Formulary, 2013 ICH Q2 (R1) “Validation of Analytical Procedures: Text and Methodology” International Conference on Harmonization. IFPMA, Geneva, Switzerland; 2005.