ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF MIRABEGRON IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLCAbstract
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.
P. R. Sankar *, K. P. Kishore, B. Babji and M. S. Sulthana
Department of Pharmaceutical Analysis, Vignan Pharmacy College, Vadlamudi, Guntur, Andhra Pradesh, India.
17 July 2019
27 November 2019
02 April 2020
01 May 2020