Development and validation of stability indicating RP-HPLC method for simultaneous estimation of silodosin and mirabegron in synthetic mixture

The study focuses to validate and develop a precise, simple and accurate stability indicating RP-HPLC method for estimation simultaneously of and silodosin and mirabegron in synthetic mixture. The chromatographic separation was achieved by using Shimpack Solar C18 column (250 x 4.5 mm, 5 mu m) with acetonitrile: 5 mM ammonium acetate in ratio of 90:10% v/v as a mobile phase at a constant flow rate of about 1.2 mL/min. The development and validation were carried out at detection wavelength of 229 nm. We developed a robust RP-HPLC method, validated for linearity, precision, accuracy, specificity, and system suitability. The method demonstrated excellent linearity with correlation coefficient value r2 was nearly 0.998 with linearity range 8-18 mu g/mL for Silodosin and 24-54 mu g/mL for mirabegron. LOD and LOQ were found to be lower; hence, the method is sensitive. Percentage recovery was obtained 99.97% and 99.99% for silodosin and mirabegron, respectively. In case of precision, robustness and repeatability, RSD was found to be less than 2. The validated and developed RPHPLC method offers an efficient and practical approach for the simultaneous quantification of silodosin and mirabegron in pharmaceutical formulations, making it a valuable tool for quality control and pharmaceutical research. (c) 2023 Academie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.