A Novel Analytical Method for Simultaneous Quantification of Silodosin and Tadalafil by RP-HPLC

Abstract

The Reverse phase HPLC method was developed for simultaneous determination of Silodosin and Tadalafil in single analytical method. Chromatographic separation was achieved on a Supelco C8 (150mmx4.6mm, 5µm) column applying an isocratic elution based on premix of potassium phosphate dibasic buffer pH (4.3) and acetonitrile in the ratio of (70:30 v/v) as mobile. Validation parameters specificity, precision and robustness have been observed to be desirable over the concentration ranges of 80-240 µg/ml for Silodosin and 50-150 µg/ml for Tadalafil in accuracy parameter and 128-192 µg/ml for Silodosin and 80-120 µg/ml for Tadalafil in linearity parameter. All the variables have been studied to optimize the chromatographic conditions. The optimized approach verified through validation and confirmed to be intended purpose for the quality control of the mentioned drugs, as per ICH guidelines. For simultaneous quantification of Silodosin and Tadalafil, the developed method was found to be genuinely exact precise, accurate, linear, fast and cost effective.