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Development and validation of RP-HPLC-UV method for simultaneous quantitation of clopidogrel bisulphate and aspirin in bulk drug

P.M.Chatrabhuji, Chintan V.Pandya, M.C.Patel

Asimple, selective, linear, precise, and accurate RP-HPLCmethod was developed and validated for the simultaneous estimation of Clopidogrel Bi Sulphate and Aspirin from bulk drug. Chromatographic separation was achieved isocratically ona ShimadzuPhenomenexLuna,C18 column (250×4.6 mm, 5 µ particle size) using a mobile phase, (0.3%ortho phosphoric acid (v/ v)-acetonitrile (40:60 v/v). The flow rate was 1 ml/min and effluent was detected at 226 nm and 20ìl of sample was injected. The retention time of Clopidogrel bisulphate andAspirin were 6.6 and 8.4 min respectively. Linearity was observed in the concentration range of 0.030-0.120 mg/ml for aspirin and 0.015-0.060mg/ml for clopidogrel. Percent recoveries obtained for for aspirin was 99.12-99.83%and 98.20-100.35%for clopidogrel. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision, LOD and LOQ.The method developed was successfully applied for the analysis of simultaneous estimation of Clopidogrel Bi Sulphate andAspirin bulk drug.