Dapoxetine Hydrochloride

UV spectroscopy is considered the simplest, the most money and time investor technique in analytical research. Besides its lowered solvent and energy consumption leading to greener outcomes, its practicality is wide and suitable for a wide range of applications. Multicomponent mixtures are always representing themselves as a problematic challenge for any analytical technique fortunately UV spectroscopic methods found many ways to tackle these mixtures. Fourier self-deconvolution (FSD) was recently applied in UV spectroscopy as an effective tool for the resolution of binary mixtures unfortunately like any other method may fail to completely resolve severely overlapping mixtures. In this paper, we epitomize the newly developed deconvoluted amplitude factor (DAF) spectrophotometric approach which couples the concepts of both the FSD and the amplitude factor methods for the resolution of tadalafil (TAD) in its binary mixtures with dapoxetine hydrochloride (DAP) or tamsulosin hydrochloride (TAM). The embraced approach was assessed regarding its greenness utilizing different assessing protocols to give evident proof for its sustainability. The innovative approach showed an enhancement in the resolution of binary mixtures and showed high sensitivity as noticed from limits of detection and quantitation which were (0.374, 1.136 μg/mL), (0.269, 0.817 μg/mL), and (0.518, 1.569 μg/mL) for TAD, DAP, and TAM, respectively. The method was validated as per ICH guidelines recommendations and also was statistically compared with recently reported methods which revealed no statistically significant difference. A very handy and reader-friendly data presentation approach was followed for the ease of statistical data interpretation and evaluation.

A green and robust high-performance thin-layer chromatographic method has been developed for the simultaneous estimation of sildenafil citrate and dapoxetine hydrochloride. A fractional factorial design was applied for analytical quality risk assessment of potential analytical risk factors. The identified critical analytical risk factors were optimized using the design of experiment-based response surface analysis by full factorial design. The analytical design space was navigated for the optimization of the method and the control strategy was framed for low-risk life-cycle management of the chromatographic method. The chromatographic analysis of sildenafil and dapoxetine was carried out on a TLC plate coated with silica gel G60 F254 using n-butanol:ethyl acetate:ethanol (8.0 + 2.0 + 0.5, v/v) as mobile phase. The chromatographic peaks of sildenafil and dapoxetine were found to be at Rf 0.29 and 0.69, respectively. The method was found to be accurate, precise, robust, specific and sensitive. The fixed-dose combinations of sildenafil and dapoxetine were assayed and results were found in compliance with their labeled claim. The present method was developed using safe and eco-friendly organic solvents for the safety of analysts and the protection of the environment. The greenness profiles of developed and reported methods were evaluated using the NEMI scale and AGREE software.