Green Stability Indicating Organic Solvent-Free HPLC Determination of Remdesivir in Substances and Pharmaceutical Dosage Forms

This study presents the development and validation of a novel, green, and solvent-free high-performance liquid chromatography (HPLC) method for the determination of remdesivir (RDS) in both its pure form and pharmaceutical dosage forms. The primary purpose was to establish a stability-indicating method capable of profiling organic degradation impurities of RDS, while also minimizing environmental impact by eliminating hazardous organic solvents. The analytical method utilized an RP-C18 stationary phase with a mixed-micellar mobile phase consisting of 0.025 M Brij-35, 0.1 M sodium lauryl sulfate (SLS), and 0.02 M disodium hydrogen phosphate, adjusted to pH 6.0. Detection was performed at 244 nm with a flow rate of 1 mL min−1. The method was validated according to ICH guidelines, demonstrating linearity in the range of 5–100 μg mL−1. Forced degradation studies were conducted under various stress conditions (acidic, alkaline, oxidative, photolytic) to assess the method's stability-indicating capability. The method successfully separated RDS from its degradation products, with alkaline hydrolysis showing the most drastic degradation effect. The study also included a greenness assessment using GAPI and AGREE metrics, highlighting its eco-friendly nature compared to existing methods, many of which rely on UHPLC-MS/MS and organic solvents. The developed method was successfully applied for the quantitative estimation of remdesivir in its marketed intravenous infusion formulation.

This study presents the development and validation of a novel, green, and solvent-free high-performance liquid chromatography (HPLC) method for the determination of remdesivir (RDS) in both its pure form and pharmaceutical dosage forms. The primary purpose was to establish a stability-indicating method capable of profiling organic degradation impurities of RDS, while also minimizing environmental impact by eliminating hazardous organic solvents. The analytical method utilized an RP-C18 stationary phase with a mixed-micellar mobile phase consisting of 0.025 M Brij-35, 0.1 M sodium lauryl sulfate (SLS), and 0.02 M disodium hydrogen phosphate, adjusted to pH 6.0. Detection was performed at 244 nm with a flow rate of 1 mL min−1. The method was validated according to ICH guidelines, demonstrating linearity in the range of 5–100 μg mL−1. Forced degradation studies were conducted under various stress conditions (acidic, alkaline, oxidative, photolytic) to assess the method's stability-indicating capability. The method successfully separated RDS from its degradation products, with alkaline hydrolysis showing the most drastic degradation effect. The study also included a greenness assessment using GAPI and AGREE metrics, highlighting its eco-friendly nature compared to existing methods, many of which rely on UHPLC-MS/MS and organic solvents. The developed method was successfully applied for the quantitative estimation of remdesivir in its marketed intravenous infusion formulation. Research Background and Significance The ongoing COVID-19 pandemic has highlighted the critical need for reliable analytical methods to ensure the quality and stability of antiviral agents such as remdesivir (RDS). Remdesivir is a nucleotide analog prodrug that has received emergency use authorization