DEVELOPMENT AND VALIDATION OF A RP-UFLC ANALYTICAL METHOD FOR THE DETERMINATION OF OPIPRAMOL IN TABLET DOSAGE FORM

A novel ultra-fast liquid chromatography (RP- UFLC) analytical method has been developed to quantify opipramol in tablet formulations. The determination was carried out by means of a Phenomenex Luna C8 Column (250×4.60mm, 5μ); potassium dihydrogen phosphate buffer of pH 2.4 and acetonitrile was used as a mobile phase in the ratio of 60:40 V/V with a flow rate of 1.00 mL/min. The photo diode array (PDA) detector was operated at wavelength of 253nm. The retention time for opipramol was found to be 2.72min. The validation studies were carried out according to ICH guidelines with a specific aim to establish that the new analytical method developed complied with the validation guidelines. The main parameters for validation study are specificity, linearity, accuracy, precision, LOD, LOQ and robustness. This method can be used for quality control analysis of opipramol in pure and marketed formulation.