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1 Acta Chromatographica

1 2007

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

100%

Antić D. , Filipić S. , Agbaba D.

2007

tom No. 18

199-206

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.