Development And Validation Of Stability Indicating UHPLC Method For The Quantitative Estimation Of Mirabegron And Solifenacin Succinate In Pharmaceutical Dosage Form

Abstract

A rapid stability-indicating UHPLC was developed and validated for the estimation of Mirabegron and Solifenacin combination in bulk and tablet dosage form using homologous mixture of mirabegron and solifenacin was injected into the Agilent-Poroshell (3 x 100 mm; 2.7μ particle size) column and eluted using mobile phase as solvent A; 10mM ammonium formate (AF) and solvent B; methanol-acetonitrile (50:50 v/v) at 0.8ml/mins flow rate for 18 mins. The proposed method was validated for the simultaneous determination of mifepristone and misoprostol in combined tablet dosage form. In comparison to previously reported methods, the performance of the proposed method was found to be rapid and cost-effective. The LOD 3.57, 1.75 µg/ml and LOQ were 11.89 and 5.82 for mirabegron and solifenacin, respectively. These results signify that the selected wavelength 210 nm is more sensitive for mirabegron and Solifenacin. The forced degradation studies using UHPLC technique revealed the possible degradation of selected drugs; mirabegron and Solifenacin under the given stress conditions including effects of acid (0.1N HCl) alkali(0.1 N NaOH), hydrogen peroxide 3% H₂O₂), and thermal condition (45-60˚C).As observed, upon exposure to all degradation conditions mirabegron was stable throughout the analysis similarly, upon exposure to all degradation conditions except NaOH degradation at +60˚C solifenacin was significantly degraded and it was found almost 5% degradation. The developed and validated stability-indicating UHPLC method was suitable for quality control and drug analysis.