Open AccessA Novel Analytical Method for Simultaneous Quantification of Silodosin and Tadalafil by RP-HPLC
Author(s) -
Ajay Kumar Gupta,
Shweta Mishra
Publication year - 2021
Publication title -
journal of pharmaceutical research international
Language(s) - English
Resource type - Journals
ISSN - 2456-9119
DOI - 10.9734/jpri/2021/v33i39b32195
Subject(s) - silodosin , tadalafil , chromatography , chemistry , phosphate buffered saline , elution , acetonitrile , high performance liquid chromatography , accuracy and precision , mathematics , medicine , lower urinary tract symptoms , statistics , erectile dysfunction , surgery , prostate , cancer
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.