ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF MIRABEGRON IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

This current study describes developing the novel, precise, simple analytical method suitable for determination of Mirabegron (MIRA) in a pharmaceutical dosage form. Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC) method was utilized for method development and validation studies of MIRA. Chromatographic separation was carried out on Agilent technologies -1260 infinity system, eclipse XDB C₁₈ column (4.6 mm i.d. × 250 mm, 5 µm particle size) at a flow rate of 1 ml/min and detection wavelength set at 251 nm. Mobile phase consists of methanol and acetonitrile were mixed in the ratio of 95:5 v/v. The retention time for MIRA was found to be 5.813 min. The calibration was linear in the concentration range of 0.2 – 1.0 µg/ml. (r² = 0.999). The limit of detection and the limit of quantitation was found to be 0.0459 μg/mL and 0.1391 µg/ml, respectively. The precision of the proposed HPLC method was found to be 0.06494 (RSD) for intraday and 0.135251 (RSD) for interday that indicates good precision of the sample MIRA analyzed. A recovery of MIRA in tablet formulation was observed in the range of 99.6 – 99.8 %. The percentage assay of MIRA (Betigma) was found to be 99.4 ± 0.1, respectively. The proposed method for MIRA was found to be accurate, precise, rapid, simple, and feasible for the estimation of MIRA in bulk as well as the pharmaceutical dosage form.