Development and Validation of Spectrophotometric Methods for the Assay of Mirabegron in Bulk and Pharmaceutical Formulations

Abstract

Simple, sensitive, precise, and validated spectrophotometric methods have been developed for the assay of Mirabegron in bulk and pharmaceutical dosage forms. The techniques are premised on the oxidation of Mirabegron with slight excess of N-bromosuccinimide (NBS), and estimating the unconsumed oxidant by assessing the amount of unreacted NBS by amaranth dye (method A), safranin dye (method B), aniline blue (method C), and rhodamine B (method D) at λmax = 530, 530, 610, and 560 nm, respectively. Under optimum conditions, Beer's law was obeyed in the concentration range of 5–30, 10–60, 20–45, and 1–15 μg/mL for methods A, B, C, and D, respectively. The proposed methods were validated in terms of specificity, linearity, range, precision, and accuracy. Furthermore, the limit of detection (LOD) and limit of quantification (LOQ) values were also calculated. The recommended methods were successfully applied to the determination of drug in pure as well as in dosage forms, without any interference from the common excipients present in pharmaceutical formulations.