Green electrochemical approach for simultaneous quantification of Dapoxetine hydrochloride and Tadalafil integrating design of experiments and functional principal component analysis

Abstract

To ensure a successful therapy for impotence and erectile ejaculation issues, tablets containing Tadalafil (TD) and Dapoxetine hydrochloride (DP) must be verified for their ingredients. This study presents a green voltammetric technique for the simultaneous determination of DP and TD. The technique is based on the unique electrochemical properties of DP and TD, and it is simple, rapid, and cost-effective. To accomplish this goal, design of experiment (DoE) and functional principle component analysis (FPCA) were applied due to the difficulty of the optimization process. The International Council on Harmonization (ICH) guidelines were used to validate the proposed method, which displayed precision for DP and TD within the concentration range of 6.7–67.0 μg mL−1. The percentage recovery values were (96.83–100.67%) and (98.27–100.90%) for DP and TD respectively. To assess the ecological impact, four greenness evaluation tools were employed, including Eco-Scale Assessment (ESA), Environmental Methods Index (NEMI), Analytical Greenness Calculator (AGREE), and Complex Green Analytical Procedure Index (Complex GAPI). The proposed method was employed on the dosage form and compared statistically to a reported HPLC method, revealing no significant differences at a 95% confidence level. The proposed method is a promising green analytical tool for the simultaneous determination of DP and TD in pharmaceutical dosage forms with good precision and accuracy. Additionally, the method is environmentally friendly, as evidenced by the greenness evaluation results. In addition, this study aims to demonstrate how the latest nonparametric technique for analyzing functional data (curves) can produce reliable results in experimental settings.