Development and validation of a liquid chromatographic method for the determination of clopidogrel from pharmaceutical dosage form

Research Institute of Pharmaceutical Sciences, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Karachi, Karachi-75270, Pakistan Department of Chemistry, University of Karachi, Karachi-75270, Pakistan E-mail : msarayne@gmail.com Manuscript received 18 July 2007, revised 15 July 2008, accepted 19 December 2008 A rapid, specific, precise and sensitive reversed-phase high-performance liquid chromatographic method was developed and validated for the determination of clopidogrel from pharmaceutical dosage form In the presence of Ourbiprofen as Internal standard. Clopidogrel and internal standard were analyzed on purospher start C18, 5 µm column having 250 x 4.6 mm i.d., with mobile phase containing methanol : water (80 : 20; pH 3.4) was used. The now rate was 1.0 mL min-1 and detector response was monitored at 235 nm. The retention time of clopidogrel and Internal standard was 4.2 min and 6.4 min respectively. Calibration curve was linear in concentration range of 0.25-50.0 µg mL -1 with coefficient of determination (r2) of 0.9994. Detection (LOD) and quantitation limits (LOQ) were 0.09 and 0.28 µg mL -1, respectively. The intra-day accuracy ranged from 96.0-103.6% with a precision of 2.30-2.86%. Similarly, the inter-day accuracy was between 98.18 and 99.99% with a precision of 1.18-10.59%