DEVELOPMENT & VALIDATION OF RP-HPLC-PDA METHOD FOR THE ESTIMATION OF OPIPRAMOL HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORMS

摘要

A simple and precise RP-HPLC method was developed and validated for the determination of opipramol hydrochloride in pharmaceutical dosage forms. Chromatography was carried out on Inertsil column(250 x 4.6mm, 5um) using a mobile phase of acetonitrile: 10mM ammonium acetate (65:35% V/V) at a flow rate of 1.2mL/min. The analyte was monitored using UV detector at 254 nm. The retention time was found to be at 5.572 min for opipramol hydrochloride. The proposed method was found to be linear in the concentration range of 10-35 pg/mL with correlation coefficient of 0.998. The mean recoveries obtained for opipramol hydrochloride were in the range of 100.23-101.81%. Limit of Detection (LOD) and Limit of Quantification (LOQ) were found to be 0.00842 and 0.0255 ug/mL, respectively. The developed method has been statistically validated according to ICH guidelines and found to be simple, precise, and accurate with the prescribed values. Thus the proposed method was successfully applied for the estimation of opipramol hydrochloride in routine quality control analysis in bulk and its formulations.