ANALYTICAL METHOD DEVELOPMENT AND VALIDATION STUDIES FOR THE ESTIMATION OF ASPIRIN, CLOPIDOGREL BISULPHATE AND ROSUVASTATIN CALCIUM IN FIXED DOSE COMBINATION (CAPSULE) BY UV SPECTROSCOPY

摘要

A simple, accurate and precise UV spectroscopy method has been developed for the simultaneous estimation of aspirin, rosuvastatin calcium and clopidogrel bisulphate in fixed dose combination (capsule). The third order derivative spectra were used and 290.36 nm, 243.84 nm and 256.16 nm were selected as detection wavelengths. A linear calibration curve was obtained in the concentration range of 20-100 mug/mL for aspirin; 6-20 mug/mL for rosuvastatin calcium and 10-100 mug/mL for clopidogrel bisulphate. The developed method was validated as per the ICH guidelines Q2(R1) for linearity, range, accuracy, precision, robustness, LOD, LOQ and system suitability.