DEVELOPMENT AND VALIDATION OF NEW ANALYTICAL RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF MIRABEGRON AND SOLIFENACIN SUCCINATE IN BULK AND MARKETED PHARMACEUTICAL DOSAGE FORM

A New Accurate, precise, Validated Analytical Method was developed for the Estimation of Mirabegron and Solifenacin Succinate in bulk and marketed pharmaceutical Dosage Form by Using UV-Visible Spectroscopy and RP-HPLC method. In UV method the maximum absorption of Mirabegron and Solifenacin Succinate was found to be 236nm and 250nm respectively. The UV Method was validated as per the ICH Guidelines. In HPLC method, the chromatographic conditions were successfully developed for the separation of Mirabegron and Solifenacin Succinate by using Symmetry C18, 5µm (4.6mm x 150mm), flow rate was 1.0 ml/min, and mobile phase was Phosphate buffer (0.02M) pH-3.8, Methanol and Acetonitrile were taken in the ratio of 60: 20: 20 % v/v, detection wavelength was 260nm. The retention times of Mirabegron and Solifenacin Succinate were found to be 2.324mins and 4.314mins respectively. The % purity of Mirabegron and Solifenacin Succinate was found to be 99.8%. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Mirabegron and Solifenacin Succinate was found in concentration range of 12µg/ml-36µg/ml and 13µg/ml -39µg/ml and correlation coefficient (r2) was found to be 0.9995 and 0.9998 respectively. The precision study was precise, robust, and repeatable. Hence the suggested UV and RP-HPLC method can be used for routine analysis of Mirabegron and Solifenacin Succinate in bulk and Pharmaceutical dosage form.