Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF ROSUVASTATIN AND EZETIMIBE IN CAPSULE DOSAGE FORM

Patel Aesha A.* and Dr. Paresh Patel

Abstract

Rosuvastatin and Ezetimibe are used for the treatment of hyperlipidemia. A stability-indicating RP-HPLC method was developed and validated for the estimation of Rosuvastatin and Ezetimibe in Capsule dosage form using Inertsil ODS 3 (100 mm x 4.6 mm i.d, 3 μm particle size) column with mobile phase consisting of Buffer solution (dissolve about 3.4 gm of Disodium hydrogen phosphate dihydrate in 1000 ml water and mix. Adjust pH of 5.0 with dilute phosphoric acid.) and acetonitrile (60:40 %v/v) with a flow rate of 1.5 ml/min (UV detection 232 nm). Linearity was observed over the concentration range 5.0-20 μg/ml for both Rosuvastatin (r2=0.9994) and Ezetimibe (r2=0.9990). The LOD and LOQ were found to be 0.0282 μg/ml and 0.0853 μg/ml for Rosuvastatin and the LOD and LOQ for Ezetimibe were 0.0297 μg/ml and 0.0901 μg/ml respectively. Rosuvastatin and Ezetimibe were subjected to stress conditions of degradation in aqueous solutions including acidic, alkaline, oxidation, Humidity and thermal degradation. The method was validated as per ICH guidelines. The percentage RSD for precision was found to be 0.4 % and 0.7 % for Rosuvastatin and Ezetimibe. The method is simple, specific, precise, robust and accurate for estimation of Rosuvastatin and Ezetimibe in Capsule dosage form. The method was successfully applied to the determination of these drugs in pharmaceutical dosage form.

Keywords: Rosuvastatin, Ezetimibe, RP-HPLC, ICH guidelines, Stability Indicating, Validation.