Analytical Method Development and Validation for The Simultaneous Estimation Of Mirabegron and Solifenacin In Bulk and Pharmaceutical Dosage Form by RP-HPLC

ABSTRACT

A rapid stability-indicating RP-HPLC was developed and validated for the estimation of Mirabegron and Solifenacin combination in bulk and tablet dosage form using Thermo C18 column (250 x 4.6 mm, 5m) as a stationary phase and a mixture solution of 0.1 percent Diazanium sulphate buffer: Acetonitrile (60:40 v/v) as the mobile phase at a flow rate of 1 ml/min. A photodiode array detector was used for detection at 246 nm. The linearity, sensitivity, selectivity, robustness, specificity, precision, and accuracy were all determined. The peak area response-concentration curve was rectilinear over the concentration ranges of 25-75 g/ml (Mirabegron) and 2.5-7.5 g/ml (Solifenacin), with quantitation limits of 0.793 g/ml (Mirabegron) and 0.307 g/ml (Solifenacin). The proposed method was validated for the simultaneous determination of mifepristone and misoprostol in combined tablet dosage form. In comparison to previously reported RP-HPLC methods, the performance of the proposed method was found to be rapid and cost-effective. The developed and validated stability-indicating RP-HPLC method was suitable for quality control and drug analysis.

Keywords: RP-HPLC, stability-indicating, tablet dosage form.