Abstract

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

M. Laksmi Monika, Sireesha D.* and Vasudha Bakshi

Abstract

A simple, accurate stability indicating reverse phase high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Rosuvastatin and Ezetimibe has been developed and validated. Chromatographic analysis was performed on Shimadzu LC- 20AD Waters X-bridge C18, 5μm (4.6 x 250mm) column at ambient temperature and a UV detector, using Acetonitrile : Methanol (30:70% v/v) as the mobile phase, with a flow rate of 1ml/min and detection wavelength at 230nm. The retention times of rosuvastatin and ezetimibe were 2.0mins and 3.0mins respectively. Calibration graphs were linear over the concentration ranges of 5-25μg/ml for both rosuvastatin and ezetimibe. The accuracy of proposed method was determined by recovery studies and was found to be 98% to 102% for both rosuvastatin and ezetimibe. To establish the stability of the method, degradation studies were carried out in acid, base, oxidation, thermal and photolytic (UV chamber) conditions and the percent degraded was calculated.

Keywords: Rosuvastatin, Ezetimibe, Degradation study, RP-HPLC.