Journal : Acta Chromatographica
Article : A simple and sensitive TLC method for determination of clopidogrel and its impurity SR 26334 in pharmaceutical products

Authors :
Bartnik, M.
Department of Pharmacognosy with Medicinal Plant Laboratory, Medical University, 1, Chodźki Str., 20-093 Lublin, Poland,
Kowalski, R.
Subdepartment of Food Quality Assessment and Central Apparatus Laboratory, Agricultural University, 20-950 Lublin, Akademicka 13, Poland,
Polak, B.
Department of Physical Chemistry, Faculty of Pharmacy, Medical University, Lublin, Poland,
Turło, J.
Department of Drug Technology, Medical University of Warsaw, 1, Banacha Street, 02-097 Warsaw, Poland,
Szyrwińska, K.
Department of Inorganic and Analytical Chemistry, Faculty of Pharmacy, Poznań University of Medical Sciences, Grunwaldzka 6, 60-780 Poznań, Poland,
Czauderna, M.
The Kielanowski Institute of Animal Physiology and Nutrition, Polish Academy of Sciences, 05-110 Jabłonna, Poland,
Bączek, T.
Medical University of Gdańsk, Department of Biopharmaceutics and Pharmacodynamics, Gdańsk, Poland,
Chilmonczyk, Z.
National Medicines Institute, 30/34, Chełmska Str., 00-725 Warsaw, Poland,
Hung, Ch. Y.
Department of Biotechnology, National Formosa University, Huwei, Yunlin, 632, Taiwan,
Baboota, S.
Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, Hamdard Nagar, New Delhi-110062, India,
Sivakumar, T.
Department of Pharmacy, Annamalai University, Annamalai Nagar, Tamil Nadu-608 002, India,
Ivanović, D.
Faculty of Pharmacy, Department of Drug Analysis, Vojvode Stepe 450, 11000 Belgrade, Serbia,
Pavlova, V.
Institute of Chemistry, Faculty of Natural Sciences and Mathematics, Saints Cyril and Methodius University, Arhimedova 5, P.O. Box 162, 1000 Skopje, Macedonia,
Ali, J.
Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, New Delhi-110062, India,
Nabi, S. A.
Analytical Research Laboratory, Department of Chemistry, Faculty of Science, Aligarh Muslim University, Aligarh-202002, India,
Murray, K. E.
Department of Chemistry, Lafayette College, Easton, PA 18042, USA,
Antić, D.
Institute of Pharmaceutical Chemistry and Drug Analysis, Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, 11000 Belgrade, Serbia,
Abstract : 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.

Keywords :
Publishing house : University of Silesia in Katowice
Publication date : 2007
Number : No. 18
Page : 199 – 206

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Qute : Bartnik, M. ,Kowalski, R. ,Polak, B. ,Turło, J. ,Szyrwińska, K. ,Czauderna, M. ,Bączek, T. ,Chilmonczyk, Z. ,Hung, Ch. Y. ,Baboota, S. ,Sivakumar, T. ,Ivanović, D. ,Pavlova, V. ,Ali, J. ,Nabi, S. A. ,Murray, K. E. ,Antić, D. ,Antić, D. , A simple and sensitive TLC method for determination of clopidogrel and its impurity SR 26334 in pharmaceutical products. Acta Chromatographica No. 18/2007