Green stability indicating RP- HPLC method for simultaneous estimation of Silodosin and Tadalafil development validation and comparative evaluation using one way ANOVA
Abstract
A novel, cost-effective, and stability-indicating isocratic RP-HPLC method was developed for the simultaneous quantification of Silodosin and Tadalafil in a synthetic mixture containing their degradation products. The method aimed to ensure sensitive, accurate, and reliable estimation of both APIs for routine quality control and stability testing. Chromatographic separation was achieved on an Inertsil C18 column using a mobile phase of phosphate buffer and methanol (34:66, v/v) at a flow rate of 1.0 mL/min with detection at 220 nm. Silodosin and Tadalafil eluted at approximately 3.810 and 10.165 min, respectively. The method exhibited excellent linearity over 40–120 µg/mL (SLD) and 25–75 µg/mL (TDF), with correlation coefficients of 0.9983 for both drugs. Accuracy studies showed recovery between 99.34 and 100.98% for SLD and 98.51–99.78% for TDF. Precision, repeatability, and robustness results were within acceptable limits (%RSD 0.05) were observed, confirming method consistency under stress. Additionally, the performance of the developed method was statistically compared with a previously published RP-HPLC method (Research Journal of Pharmacy and Technology, 2025). ANOVA demonstrated that the present method offers comparable or superior analytical performance, supporting its enhanced precision, sensitivity, and stability-indicating efficiency. The validated RP-HPLC method meets ICH Q2(R2) requirements and proves robust, accurate, sensitive, and environmentally sustainable,…
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