Development and validation of stability Indicating methods for some pharmaceutical Compounds by hplc and its application to Dosage forms

Abstract

newline This research work was designed to establish and validate a novel stability indicating RP-HPLC method for thecombined determination of Benidipine hydrochloride (BHE) and Nebivolol hydrochloride (NHE) in bulk andtablets, dependent on ICH guidelines.The assay method to analyse BHE and NHE was optimized with isocraticelution using acetonitrile: 0.1M acetate buffer (45:55, pH 5.1), Lichrospher ODS RP-18 column and flow pace of1 ml/min. Total time for single run was 14 min. The injection quantity was 20and#956;l, and was detected at 249nm. Themethod was verified on a concentration series of 1.25-10and#956;g/ml (NHE) and 1.0-10and#956;g/ml (BHE) for precision,accuracy and linearity. newline