Stability-indicating liquid chromatography for determination of clopidogrel bisulfate in tablets: Application to content uniformity testing

AbstractThe present study describes a simple stability-indicating reversed-phase HPLC assay for antiplatelet drug, clopidogrel bisulfate. Separation of the drug and the degradation products, under stress conditions was successfully achieved on a C-18 column utilizing 0.01M Na2HPO4 (pH 4): acetonitrile in the ratio 80:20 v/v, pumped at a flow rate of 0.5mlmin−1 with UV detection at 235nm. The retention time of clopidogrel was 6.84min. The method was satisfactorily validated with respect to linearity, precision, accuracy, selectivity, sensitivity and ruggedness. The response was linear in the range of 0.2–3.5μgml−1 with detection limit 0.079μgml−1. The suggested method was successfully applied for the analysis of clopidogrel in bulk and in commercial tablets. The results were favorably compared to those obtained by a reference method. The proposed method was successfully applied to the content uniformity testing of tablets and for determination of clopidogrel in presence of its co-administered drug, acetyl salicylic acid