Quantification of β-Adrenergic Receptor Agonist Drug Mirabegron in Presence of Degradants by High Performance Thin Layer Chromatography

Abstract

A sensitive, selective, accurate, precise and robust thin layer chromatographic method has been developed and validated for the estimation of β-Adrenergic Receptor agonist drug Mirabegron in bulk and pharmaceutical formulation. Aluminium supported plates pre-coated with silica gel 60F-254 was used as stationary phase while methanol: acetonitrile: triethylamine (4: 6: 0.1, v/v/v) mixture saturated in twin trough chamber was used as mobile phase. The Rf values of Mirabegron was observed to be 0.58 ± 0.0089. The detection was carried out in absorbance mode at 247 nm. Linear regression analysis data showed linear relationship for Mirabegron over a concentration range of 100-1200 ng/band. Forced degradation study showed drug was susceptible to acid and alkali hydrolysis, chemical oxidation and photo degradation. The degraded product peaks of Mirabegron were well resolved from the parent peak as data obtained from their significant Rf values. The method was validated and data from forced degradation study showed that the method can be used for quantifying Mirabegron in marketed formulation.