Development and Validation of a RP-HPLC Method for the Simultaneous Estimation of Ranitidine Hydrochloride and Dicyclomine Hydrochloride in Tablet Dosage Forms

An accurate, precise and reproducible high performance liquid chromatographic method was developedfor simultaneous estimation of Ranitidine Hydrochloride and Dicyclomine Hydrochloride in tabletdosage forms. Chromatographic separation of the drugs were achieved on a Phenomenax C18 column(150 x 4.6 mm; 5μ) using a mobile phase consisting of ortho-Phosphoric acid 0.1% and Acetonitrile pH3.5 (25:75, %v/v) at a flow rate of 0.5 ml/min. The drugs elute were monitored at 218 nm. The retentiontime obtained for the Ranitidine Hydrochloride was 4.32 min and for the Dicyclomine Hydrochloridewas 5.96 min. The calibration curves were linear over the range of 5-25 μg/ml and 50-250 μg/ml forRanitidine Hydrochloride and Dicyclomine Hydrochloride respectively. The performance of the methodwas validated according to ICH guidelines. The method could be applied for determination of in itstablet dosage forms without any interference from excipients or endogenous substances. The proposedmethod is suitable for routine quality control analysis.