Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CLINIDIPINE AND OLMESARTAN WITH FORCED DEGRADATION STUDIES IN BULK AND TABLET DOSAGE FORM

Ganipisetty Lakshmi Aswini*, D.Dachinamoorthy, J.V.L.N.Seshagiri Rao

Abstract

Stability indicating reversed-phase high-perfomance liquid chromatographic (RP-HPLC) method has been developed and validated for the simultaneous estimation of cilinidipine and olmesartan. All the drugs were separated on ODS 250x 4.6 mm, 5. The mobile phase was a 60:40 (v/v) mixture of acetonitrile and 0.1%orthophosphoric acid buffer, pumped at a flow rate of 1 ml/min. UV detection was performed at 270 nm. The retention time of cilinidipine and olmesartan was found to be 2.382 min and 3.687 min respectively. The method was validated in the sample concentration ranges of 50-300μg/ml for cilinidipine and 25 – 150 μg/ml for Olmesartan. The method demonstrated to be robust, resisting to small deliberate changes in pH and flow rate of the mobile phase. The LOD values were 0.26 μg/ml and 10.3 μg/ml, while the LOQ values were 0.87 μg/ml and 31.1 μg/ml for cilinidipine and olmesartan respectively. The recoveries for all three levels were above 99%.

Keywords: RP-HPLC, cilinidipine and olmesartan, Tablet dosage form, forced degradation.