Stability Indicating RP-HPLC Method Development and Validation for Dutasteride and Silodosin Combination of Drugs in Pharmaceutical Dosage Forms

Abstract

This research work outlines the advancement & verification of a HPLC technique for the parallel quantification of Dutesteroid & Silodosin using an Inertsil C18 column with a MP composed of phosphate buffer &ACN. The chromatographic conditions were optimized for a detection at 235 nm, with a flow speed of 1 ml per min and an  volume injected of 20 µl. Key validation parameters including specificity, linearity, precision, ID precision,accuracy,LOD, LOQ, and robustness were assessed, demonstrating that all values met established limits. The technique exhibited linearity over the conc. extent 20 µg/ml to 100 µg/ml, yielding high correlation coefficients (R² > 0.999). Precision studies showed low %RSD values, indicating technique reliability. Degradation studies revealed minimal degradation under different stress conditions, supporting the method's robustness. Overall, the verified HPLC technique is suitable for regular quantitative analysis of Dutesteroid & Silodosin in pharmaceutical formulations.