UPLC Estimate of Sofosbuvir and Ledipasvir Utilizing Greenness Tool in Conjunction With an Analytical Quality by Design.

Abstract

Ledipasvir in combination with sofosbuvir approved by regulatory bodies used to treat chronic hepatitis C. The present work investigates the design and development of a new, quick, green, and selective UPLC (ultra-performance liquid chromatography) approach to concurrently quantify sofosbuvir and ledipasvir. Optimization with Box-Behnken design paired the green analytical method and quality by design-based risk assessment. A mobile phase of 65%:35% ethanol by volume and phosphate buffer (15 mM; pH 3.0) was used, with a flow rate of 0.28 mL per minute, to achieve the best chromatographic separation. With linearities ranging from 20 to 100, 4.5-22.5 μg/mL, and R² values of 0.9999 and 0.9997, respectively, the established UPLC-PDA technique proved sensitive and specific for sofosbuvir and ledipasvir. The stability-indicating test findings demonstrate the degradation under the relevant stress conditions. The most environmentally friendly results were found when the level of environmental sustainability was evaluated using four advanced metrics: GAPI, AES, AMGS, and AGREE. Based on the findings, we came to the conclusion that the UPLC technique that was developed would be effective for the concurrent analysis of sofosbuvir and ledipasvir in tablet medication.