An Innovative Reverse-Phase High-Performance Liquid Chromatography Technique For Measuring Finasteride And Tadalafil In Raw Materials And Pharmaceutical Products With Stability Indication

Abstract

This study aims to develop and validate a novel, advanced Stability indicating Reverse-Phase High-Performance Liquid Chromatographic (RP-HPLC) method for the simultaneous quantification of Finasteride and Tadalafil. The proposed technique employs Zorbax Eclipse Plus, C18, 100 x 4.6 x 3.5µ, utilizing a mobile phase composition of Water: ACN (60:40) %v/v to achieve effective separation. The method employs a detection wavelength of 215nm, a flow rate of 1.0mL/min, and an injection volume of 10μL. The linearity ranges for both Finasteride and Tadalafil were established at 25 – 75μg/mL. Retention Times were determined to be 7.551min for Finasteride and 4.071min for Tadalafil. The Percent Recovery results for both compounds fell within the 98 – 102%w/w range. The method underwent successful validation according to ICH guidelines. Forced degradation studies were conducted, and the method did not detect any degradation compounds, confirming its accuracy. Based on the analysis of the results obtained, this newly developed method proves to be cost-effective and dependable for routine analysis across all validated parameters.