Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TELMISARTAN CILINIDIPINE AND CHLORTHALIDONE IN BULK AND THEIR COMBINED TABLET DOSAGE FORM WITH FORCED DEGRADATION STUDIES

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

Abstract

An accurate reproducible and efficient stability indicating reversedphase high-perfomance liquid chromatographic (RP-HPLC) method has been developed and validated for the simultaneous estimation of Telmisartan, cilinidipine and chlorthalidone. All the drugs were separated on a ODS 150 x 4.6 mm, column packed with 5 Âμm particles. The mobile phase, optimized through an experimental design, was a 50:50 (v/v) mixture of sodium dihydrogen Ortho phosphate buffer and Acetonitrile (pH 3.0 ), pumped at a flow rate of 1 ml/min. UV detection was performed at 240 nm. The retention time of Telmisartan, cilinidipine and chlorthalidone was found to be 3.468min, 7.178min and 2.161min respectively. The method was validated in the sample concentration ranges of 20-120 μg/ml for Telmisartan, 5-30 μg/ml for cilinidipine and 6.25-37.5 μg/ml for chlorthalidone. The method demonstrated to be robust, resisting to small deliberate changes in pH and flow rate of the mobile phase. The LOD values were 0.02μg/ml,0.15 μg/ml and 0.04μg/ml, while the LOQ values were 0.06μg/ml, 0.45μg/ml and 0.12μg/ml for telmisartan, cilinidipine and chlorthalidone respectively.

Keywords: RP-HPLC, Telmisartan Cilinidipine and Chlorthalidone, Tablet dosage form, forced degradation.