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.
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