Green Analytical Method Development and Validation Studies of Viloxazine Hydrochloride in Pure and Commercial Products Using UV-Vis Spectroscopy

Abstract

The present work describes the development and validation of zero-order derivative and first-order derivative UV-Vis spectrophotometric methods for the quantitative determination of viloxazine hydrochloride. The spectrophotometric determination was performed within 200–400 nm and the first-order derivative spectrum was obtained by comparing absorbance to wavelength. The developed method was validated under ICH guidelines for linearity, precision, accuracy, limits of detection and quantification, and robustness. The correlation coefficient value of the methods was 0.9989 (method A) and 0.9979 (method B) with a limit of detection of 3 μg/mL and a limit of quantification of 9 μg/mL. The precision of the methods was confirmed by calculating the %relative standard deviation, which is acceptable as per guidelines. The accuracy of the methods was calculated and represented in terms of % mean recovery. Moreover, the greenness profiles of the developed UV method were assessed using the green analytical procedure index (GAPI) and the AGREE evaluation method. The results revealed adherence of the described method to the green analytical chemistry principles. We successfully developed and validated the UV method according to ICH guidelines. The method was proved for the analysis of marketed formulations.