Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS ESTIMATION OF CILNIDIPINE AND IRBESARTAN IN PHARMACEUTICAL DOSAGE FORM

Chandani Soni*, Dr. C. J. Patel and Dr. M. M. Patel

Abstract

A simple, sensitive, accurate, rapid and economical RP-HPLC method was developed and validated for the determination of Irbesartan and Cilnidipine in pharmaceutical dosage form. Chromatography was performed on a Hypersil C18 BDS column (25cm x 0.46 cm) and Phosphate Buffer (pH 4.5): Methanol in the ratio (85:15) as mobile phase at a flow rate of 1 ml/min. Wavelength of detection used was 248 nm. The retention time of Cilnidipine and Irbesartan was obtained as 5.343 min and 4.080 min respectively. The obtained calibration curve was linear in the concentration range of Cilnidipine is 0.5-1.5 μg/ml and for Irbesartan is 15-45 μg/ml. The LOD and LOQ was found to be 1.167 μg/ml and 3.538 μg/ml for Irbesartan and 0.046 μg/ml and 0.139 μg/ml for Cilnidipine respectively. The method was successfully applied for the analysis of drugs in pharmaceutical formulation. Results of the analysis were validated statistically and by recovery studies.

Keywords: Irbesartan, Cilnidipine, stability indicating RP-HPLC method, validation.