A Simple and Sensitive Tlc Method for Determination of Clopidogrel and Its Impurity Sr 26334 in Pharmaceuticals

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) 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.