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.