Exploring stationary phase morphologies as pathways to greener and faster LC for analyzing sofosbuvir and ledipasvir

Abstract

Green chemistry has a beneficial influence on the environment and the pharmaceutical enterprises’ economy. Research and quality control laboratories worldwide conduct millions of analyses daily, employing liquid chromatography as the primary analytical technique. Furthermore, advancements in stationary phase technologies aimed at achieving faster and more efficient separations have introduced a new objective for chromatographers. This objective is to supersede conventional methodologies that rely heavily on substantial quantities of organic solvents, pose environmental hazards and incur considerable economic costs. The aim of this work is to provide a brief comparison between monolithic, core-shell and traditional fully porous stationary phases. This could help analysts by offering options for high-speed versus high-resolution separation when choosing the best packing materials. The analytes used in the study are two essential drugs used in the treatment of hepatitis C virus: Sofosbuvir and Ledipasvir, which are co-formulated in tablet dosage forms. The monolithic column enabled the fastest analysis, whereas the core-shell provided the highest efficiency. Validation was conducted in accordance with ICH guidelines using the RP-C18 monolithic column, a mobile phase consisting of 0.1% acetic acid and ethanol (60:40), a flow rate of 1 mL.min^{− 1}, and detection at 210 nm. The total analysis time did not exceed 3 min, achieving high accuracy and sensitivity while minimizing the use of hazardous solvents. It achieved a very good score on different green analytical chemistry assessment metrics; 0.7 on AGREE, 76 on MoGAPI, 80 on BAGI, and 73 on CACI.