UV-Vis Spectrophotometric Method Development and Validation of Mirabegron Via Green Approach

Abstract

An innovative, meticulously crafted, targeted, expeditious, precise, and cost-effective methodology was pioneered utilizing UV-Vis spectrophotometry for the quantitative determination of Mirabegron in both its pristine state and pharmaceutical tablet formulation. Following thorough deliberation on factors such as solubility, stability, toxicity, and carcinogenicity, petroleum ether emerged as the solvent of choice, aligning with the principles of environmentally conscious methodology. The absorption maxima were unequivocally detected at a wavelength of 250 nm, making petroleum ether the solvent of choice. The method adheres faithfully to Beer's law within a concentration range spanning from 0.004 to 0.016 mg/mL, boasting a remarkable correlation coefficient of 0.9945. LOD and LOQ were meticulously computed from the dataset, yielding values of 0.0001663 and 0.0005039, respectively. The relative standard deviation, meticulously derived from the dataset, stands at less than 2%. Moreover, in the rigorous accuracy assessment, Mirabegron's recovery percentage fell impressively within the narrow band of 98.62 to 101.46%. During both the intraday and interday precision evaluations, the %Assay remained consistently within the stringent range of 99.63 to 101.12%, affirming the method's precision. Furthermore, adherence to the rigorous guidelines outlined in ICH Q2 (R1) was ensured throughout the comprehensive validation process, consolidating the method's credibility and suitability for analytical applications.