Simultaneous estimation of rosuvastatin calcium and ezetimibe inpharmaceutical formulation by RP-HPLC method with forced degradationstudies

A simple, specific, accurate and precise RP-HPLC method was developed and validated for the simultaneous estimation of Rosuvastatin Calcium and Ezetimibe in pharmaceutical formulation with forced degradation studies. The method was developed using Enable C 18G column (250 ×4.6 mm, 0.5 μm) with mobile phase consisted of acetonitrile and 1 % acetic acid in water at the ratio of 80:20 %v/v with a flow rate of 1 mL/min .UV detection was carried out at 252 nm. The retention time for Rosuvastatin Calcium and Ezetimibe were found to be 2.928 and 6.553 min respectively. The proposed method was validated for linearity, range, accuracy, precision, robustness, LOD and LOQ. Linearity was observed over a concentration range 0.5-250 μg/ml for Rosuvastatin Calcium (r2 =0.9978) and 0.5-250 μg/ml for Ezetimibe (r2 =0.9991). The % RSD for Intraday and Interday precision was found to be 0.56 and 0.36 for Rosuvastatin Calcium and 0.50 and 0.32 for Ezetimibe. The LOD and LOQ were found to be 0.04 μg/ml and 0.16 μg/ml for Rosuvastatin Calcium and LOD and LOQ were found to be 0.03 and 0.11 μg/ml for Ezetimibe respectively. Rosuvastatin Calcium and Ezetimibe were subjected to stress conditions of degradation including acidic, alkaline, oxidative, thermal and photolysis.