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A simple and sensitive TLC method for determination of clopidogrel and its impurity SR 26334 in pharmaceutical products

Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
A simple, conventional TLC method has been established for separation of clopidogrel and its hydrolytic product SR 26334, the main impurity in clopidogrel. Use of aluminium foil-backed silica gel 60F254 plates with n-heptane–tetrahydrofuran, 1:1 (v/v), as mobile phase, enabled successful separation of clopidogrel in high excess from the impurity. The separated compounds were detected at 230 nm. Regression coefficients (r ≥ 0.999), recovery (94.5–107.1%), and limit of quantification (0.047 mg mL-1) were evaluated and found to be satisfactory. The method is convenient for quantitative analysis and purity control of clopidogrel both in raw material and in dosage forms.
Słowa kluczowe
Rocznik
Tom
Strony
199--206
Opis fizyczny
Bibliogr. 13 poz., rys., tab.
Twórcy
autor
autor
autor
  • Institute of Pharmaceutical Chemistry and Drug Analysis, Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, 11000 Belgrade, Serbia
Bibliografia
  • [1] S.J. Cutler and G.H. Cocolas, in: J.H. Block and J.M. Beale (eds), Wilson and Gisvold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry, Lippincott Williams and Wilkins, Philadelphia, 2004, pp. 622–675
  • [2] J.A. Coukell and A. Markham, Drugs, 54, 745 (1997)
  • [3] A. Mitakos and I. Panderi, Anal. Chim. Acta, 505, 107 (2004)
  • [4] H. Ksycińska, P. Rudzki, and M. Bukowska-Kiliszek, J. Pharm. Biomed. Anal., 41, 533 (2006)
  • [5] J. Grenier, S. Ciric, J. Curry, G. Morelli, A. Arseneault, and M. Tanguay, Clin. Pharmacol. Ther., 73, P47 (2003)
  • [6] D. Taubert, A. Kastrati, S. Harlfinger, O. Gorchakova, A. Lazar, N. von Beckerath, A. Schomig, and E. Schomig, Thromb. Haemost., 92, 311 (2004)
  • [7] A. Lainesse, Y. Ozalp, H. Wong, and R. Alpan, Arzneim. – Forsch./Drug Res., 54, 600 (2004)
  • [8] P. Lagorce, Y. Perez, J. Ortiz, J. Necciari, and F. Bressolle, J. Chromatogr. B, 720, 107 (1998)
  • [9] A. Mitakos and I. Panderi, J. Pharm. Biomed. Anal., 28, 431 (2002)
  • [10] H.Y. Aboul-Enein, H. Hoenen, A. Ghanem, and M. Koll, J. Liq. Chromatogr. Related Technol., 28, 1357 (2005)
  • [11] Y. Gomez, E. Adams, and J. Hoogmartens, J. Pharm. Biomed. Anal., 34, 341 (2004)
  • [12] H. Agrawal, N. Kaul, A.R. Paradkar, and K.R. Mahadik, Talanta, 61, 581 (2003)
  • [13] United States Pharmacopoeia, 29th edn, United States Pharmacopeial Convention, Rockville, MD, 2006
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-article-BAT8-0006-0031
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