Concurrent estimation of clopidogrel bisulfate and aspirin in tablets by validated RP-HPLC method

Abstract

A simple, rapid, precise RP-HPLC method was developed for simultaneous estimation of aspirin and clopidogrel bisulphate in tablet dosage form used in the treatment of cardiovascular diseases. To achieve the maximum resolution, acetonitrile:50 mM potassium dihydrogen phosphate buffer:methanol, solution pH adjusted to 3, in the ratio 50:30:20; v/v was selected as mobile phase. This mixture was found to be appropriate allowing good separation of both the components at a flow rate of 1.5 ml/min and detection wavelength 240 nm. In these conditions clopidogrel bisulfate and aspirin were eluated at the 7.47 and 2.2 min. The linearity was found in the concentration range 1.5-7.5 and 3.5-15.0 μg/ml, respectively. All the analytical validation parameters were determined and found with in the limit as per ICH guideline, which indicates the validity of method.