Development, validation and forced degradation studies of green liquid chromatographic method for determination of remdesivir in bulk drug and pharmaceutical formulation

• Published in: Pakistan journal of pharmaceutical sciences Vol. 36; no. 1; pp. 159 - 170
• Main Authors: Abdul Samad, Hafiz, Nadir Ali, Saeeda, Qayoom, Amtul, Haroon, Urooj, Saad, Muhammad, Mumtaz Alavi, Ghina
• Format: Journal Article
• Language: English
• Published: Pakistan Pakistan Journal of Pharmaceutical Sciences 01-01-2023
• Subjects: Chemistry, Analytic; Chromatography, High Pressure Liquid - methods; COVID-19; COVID-19 Drug Treatment; Decomposition (Chemistry); Drug Compounding; Drug Stability; Green chemistry; Humans; Liquid chromatography; Methods; Pharmaceutical Preparations; Pharmaceutical research; Quantitative; SARS-CoV-2; Pakistan
• ISSN: 1011-601X
• DOI: 10.36721/PJPS.2023.36.1.REG.159-170.1

Remdesivir was recently approved by Food and Drug Administration (FDA) to treat severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease. In this study, we report development of the green and reversed-phase liquid chromatographic method for quantitative determination of remdesivir in pharmaceutical formulations in forced degradation studies using mobile phase consisting of 0.4% trifluoroacetic acid: Acetonitrile with flow rate of 1.0mL min
. High performance liquid chromatographic stability-indicating procedure was evaluated and impurities were profiled by subjecting the remdesivir under stress conditions i.e. acidic and alkaline hydrolysis, oxidative and thermal degradation. The developed method effectively separated the parent drug response from that of degradation products and it was validated following ICH guidelines within linearity range of 5-50µg mL
exhibiting correlation coefficient greater than 0.997. At all levels, the % RSD values were less than 2.0 indicating satisfactory precision. Green profile of developed method was evaluated by NEMI and AGREE tools. Comparison of proposed method with already existing chromatographic method was established using analytical eco-scale. The proposed method is eco-friendly and resulted in reliable quantification of remdesivir in dosage formulation and impurity profiling.