RP-HPLC METHOD DEVELOPMENT AND VALIDATION STUDIES FOR THE ESTIMATION OF ASPIRIN, CLOPIDOGREL BISULPHATE AND ROSUVASTATIN CALCIUM IN FIXED DOSE COMBINATION CAPSULESAbstract
The present project was conducted with the objective of developing and validating a RP-HPLC method for the simultaneous estimation of aspirin, clopidogrel bisulphate, and rosuvastatin calcium in fixed-dose combination capsule. The chromatographic separation was carried out on Agilent 1260 series using Waters C18 (250 × 4.6 mm, 5 μ) column as the stationary phase and acetonitrile (ACN): phosphate buffer pH 3, gradient mode at a flow rate of 1.2 ml/min and detection at 230 nm. The validation of the developed method was conducted as per the ICH guidelines Q2 (R1). The retention time of aspirin, rosuvastatin calcium and clopidogrel bisulphate was found to be 3.2 min, 4.7 min, and 12.8 min, respectively, under the optimized chromatographic conditions. The developed method was linear in the concentration range of 6.25-400 μg/ml for aspirin, rosuvastatin calcium, and clopidogrel bisulphate. The developed method was specific, with a mean percent recovery of the three drugs in the range of 99-101%. The relative standard deviation (RSD) was less than 2 in the intraday and inter-day precision studies. A simple, accurate, robust, and precise RP-HPLC method was developed for the simultaneous estimation of aspirin, rosuvastatin calcium, and clopidogrel bisulphate in fixed-dose combination capsule. The developed method was validated for linearity, range, accuracy, precision, robustness, LOD, LOQ, and system suitability. This method can be conveniently used for quantification of the three drugs in fixed-dose combination products.