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 10 to 100 µg/mL. Successful separation was achieved by isocratic elution on a Restek C18 column (250 mm × 4.6 mm, 5μm). The mobile phase was composed of buffer pH: 7.0 potassium dihydrogen phosphate and acetonitrile (60:40 v/v) at the flow rate of 1 mL/min using UV detection at 249 nm, column oven temperature 45°C and injection volume 10 μL. The analytical results were validated by recovery studies. The percentage recovery method was found to be 99.00-101.17%. The LOD and LOQ were found to 0.015 μg/mL and 0.049 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.