RP-HPLC Method Development and Validation for the Quantitative Estimation of Mirabegron in Extended-Release Tablets

In this study, we describe and validate a rapid and sensitive method for constitution of Mirabegron in the Extended-Release tablets by RP-HPLC. The assay method by HPLC was found to be linear in the concentration range of ۱۰ to ۱۰۰ µg/mL. Successful separation was achieved by isocratic elution on a Restek C۱۸ column (۲۵۰ mm × ۴.۶ mm, ۵μm). The mobile phase was composed of buffer pH: ۷.۰ potassium dihydrogen phosphate and acetonitrile (۶۰:۴۰ v/v) at the flow rate of ۱ mL/min using UV detection at ۲۴۹ nm, column oven temperature ۴۵ºC and injection volume ۱۰ 𝜇L. The analytical results were validated by recovery studies. The percentage recovery method was found to be ۹۹.۰۰-۱۰۱.۱۷%. The LOD and LOQ were found to ۰.۰۱۵ μg/mL and ۰.۰۴۹ μg/mL. All the parameters of validation were in the acceptable range. This developed method was successfully applied for estimate the amount of Mirabegron in the tablets.