A validated LC method for the determination of clopidogrel in pharmaceutical preparations

A stability indicating, reversed-phase high-performance liquid chromatographic method was developed and validated for the determination of clopidogrel in pharmaceutical dosage forms. The determination was performed on a semi-micro column, BDS C8 (250 x 2.1 mm i.d., 5 mum particle size); the mobile phase consisted of a mixture of 0.010 M sodium dihydrogen phosphate (pH 3.0) and acetonitrile (35:65, v/v), pumped at a flow rate 0.30 ml min(-1). The UV detector was operated at 235 nm. The retention times for clopidogrel and naproxen, which was used as internal standard, were 3.08 and 6.28 min, respectively. Calibration graphs are linear (r better than 0.9991, n = 6), in concentration range 1.00-3.00 mug ml(-1) for clopidogrel. The intra- and inter-day RSD values were less than 1.96%, while the relative percentage error E, was less than 2.0% (n = 5). Detection and quantitation limits were 0.12 and 0.39 mug ml(-1), respectively. The method was applied in the quality control of commercial tablets and content uniformity test and proved to be suitable for rapid and reliable quality control. (C) 2002 Elsevier Science B.V. All rights reserved.