Two birds with one stone: sustainable smart spectrophotometric methods for concurrent determination of silodosin and mirabegron: application to dosage forms and greenness assessment

Abstract

A new combination of silodosin and mirabegron has recently obtained approval in the Indian market for addressing the benign prostatic hyperplasia symptoms associated with overactive bladder syndrome. In this study, we present four validated UV-spectrophotometric methods that rely on straightforward mathematical calculations for the quick and simultaneous assay of MRB and SLD in commercial tablets and synthetic mixes without the need for prior separation. The suggested methods include dual-wavelength, induced dual-wavelength, ratio difference, and area under the curve. These methods were effectively used to determine SLD and MRB simultaneously in combinations with severe spectrum overlap, showing excellent recoveries free from interference from pharmaceutical excipients. The proposed approaches were assessed and validated following the guidelines set forth by the International Conference for Harmonization (ICH). The methods exhibited linear ranges of 1–20 μg mL⁻¹ and 1–25 μg mL⁻¹ for SLD and MRB, respectively. Their environmental friendliness was assessed using the Analytical Greenness Calculator (AGREE) and The Green Analytical Procedure Index (GAPI) tools, demonstrating their supremacy in terms of greenness compared to the reported chromatographic method. There were no appreciable variations in accuracy or precision between the reported chromatographic method and statistical comparisons based on t- and F values. Consequently, these suggested methods are deemed effective in routine analysis of SLD and MRB, serving as cost-effective alternatives in quality control laboratories lacking expensive chromatographic instruments.