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

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 60F(254) 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. Regession 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.