DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE DETERMINATION OF CANDESARTAN CILEXETIL IN BULK DRUG AND TABLET DOSAGE FORM

摘要

A convenient, simple, accurate, precise and reproducible Reverse Phase High Performance Liquid Chromatographic method was developed and validated for the estimation of candesartan cilexetil in bulk drug and tablet dosage form. The separation was achieved in less than 5 minutes using Dionex C18 column on 250 x 4.6 mm id, 5 urn particle size, mobile phase acetonitrile and phosphate buffer pH 4.0 in the ratio of 70:30 v/v at a flow rate of 1 mL/min. The effluent was monitored at 254 nm using diode array detector. Injecton volume applied was 10 uL The retention time of candesartan cilexetil was found to be 2.14 minutes and the standard calibration plot was found linear over the range of 10-200 ppm. The LOD and LOQ were found to be 5.61 ppm and 17 ppm respectively. The developed method was validated according to International Conference on Harmonization (ICH) guidelines for specificity, linearity, range, accuracy, precision, detection limit, quantitation limit, robustness and system suitability parameters.