Journal of Bioequivalence & Bioavailability

Simultaneous determination of aspirin, clopidogrel bisulphate and atorvastatin calcium in capsule dosage form by RP-HPLC

3^rd World Congress Bioavailability & Bioequivalence

March 26-28, 2012 Marriott Hotel & Convention Centre, Hyderabad, India

M. Vanitha Sri

Posters: J Bioequiv Availab

Abstract:

A simple, rapid, reliable and precise reversed phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of aspirin (ASP), clopidogrel bisulphate (CLP) and atorvastatin calcium (ATV) from capsule dosage form. Chromatography was carried out at 10?C on a 50 x 2.5 mm i.d., 5 μm Equisil ODS column with isocratic mobile phase 0.1% orthophosphoric acid and acetonitrile (50:50% v/v) at a flow rate of 1.0 mL/min. The detection was carried out with UV-visible detector at 245 nm. The retention times were about 1.09, 1.24 and 2.99 min for ASP, CLP and ATV, respectively. The total runtime was less than 4 min. The method was validated according to ICH guidelines and the acceptance criteria for accuracy, precision, linearity, specificity and system suitability were met in all cases. The method was linear in the range of 12-48 μg/mL for ASP, 12-48 μg/mL for CLP and 3-12 μg/mL for ATV. Limit of detection obtained were 0.03μg/mL for ASP, 0.06μg/mL for CLP and 0.07μg/mL for ATV. The percentage recoveries were found to be 98% for ASP, 96% for CLP and 93.3% for ATV. The proposed method can be used for the estimation of these drugs in combined dosage form