Chiral HPLC Method Development And Validation For The Estimation Of S-Viloxazine And FD Characterization By MS

In the present work, aim to develop and validate a new High-Performance Liquid Chromatography (HPLC) method performing chiral separation for estimation of s-viloxazine and foerced degradation characterization. Optimization led to the development of an enantioselective method for rapid detection and quantitative analysis, with baseline resolution at purity levels in a simple hplc s-viloxazine degradation products utilizing chiral stationary phase. The parameters like mobile phase composition, column temperature and flow rate were systematically optimized for the best separation of peaks with good resolution. Quaternary gradient pump of e2695 series with auto sampler injector in which 10µl was injected and eluted using mobile phase consisting Methanol: n-hexane, IPA (30:50; 20 v/v) at a flow rate of 1ml/min, chiralpack IM, 250x10mm,(C-18 chrial column )5 µm) was used for sample separation, and UV detector set at λmax264.6nm were employed as analytical tools for the quantification analysis. The method developed was found to be both specific, linear as well as precise accurate and robust. The drug was stressed under different stress condition like acid, alkali, peroxide, reduction, photolytic, hydrolysis and thermal degradation. However, stress degradation studies were conducted to generate 4 major degradation products which are DP-1, Dp-2, Dp-3, and Dp-4 respectively. The formed degradation products are subjected to mass characterization. The results for the chosen drug's recoveries were found to be within acceptable ranges (98–102%).