Document Type : Original Article

Authors

1 Department of Pharmaceutical Science, Faculty of Health Sciences, Marwadi University, Rajkot-Morbi Highway, Rajkot, Gujrat, 360003, India

2 B.K. Mody Government Pharmacy Collage, Rajkot, Gujrat, India

10.48309/jmnc.2024.435126.1016

Abstract

The simultaneous measurement of Mirabegron and Silodosin in a synthetic mixture was made possible by the development and validation of a rapid and precise ultraviolet-visible (UV-Vis) spectrophotometric method. The simultaneous Estimation of Mirabegron and Silodosin was carried out at specific wavelengths, specifically 268.25 nm (Zero Crossing Point of Silodosin) and 249.54 nm (Zero Crossing Point of Mirabegron), using UV detection for the first-order derivative method. It was observed that there was no interference from the diluents at these wavelengths. The method demonstrated linearity within the concentration range of 3.125-62.5 µg/mL for mirabegron and 1-20 µg/mL for silodosin. The results indicated that the correlation coefficients for mirabegron and silodosin were 0.996 and 0.995, respectively. The accuracy ranges for the Silodosin and Mirabegron were determined to be 99.84-100.61% and 98.54-102.09%, respectively. The limits of detection and quantitation for mirabegron were determined to be 1.35 μg/mL and 4.10 μg/mL, respectively. The results showed that silodosin has a limit of quantitation of 19.71 μg/mL and a limit of detection as 6.50 μg/mL. It was found that the precision and repeatability analysis's RSD was less than 1. The approach was verified in accordance with the ICH Q2R1 standard. The results demonstrated that the suggested method involves the mixing of Mirabegron and silodosin in a synthetic mixture. A simple, specific, accurate, exact, and reliable UV-visible spectroscopic Method has been developed and validated in this study

Graphical Abstract

Spectroscopic method development and validation of drug used in treatment of benign prostatic hyperplasia complicated with over active bladder

Keywords

Main Subjects

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