Abstract
A green liquid chromatographic method is considered in this work to minimize the environmental impact of waste solvents. One important principle is to replace or eliminate the use of hazardous organic solvents. Organic impurities in any active pharmaceutical ingredient could arise either during the process of its synthesis, or as degradation products developed throughout the shelf-life. Remdesivir (RDS) is an antiviral drug, approved by the US Food and Drug Adminstration (-FDA), to treat SARS-Cov-2 virus during its pandemic crisis. We studied the stability of remdesivir against several degradation pathways using the organic solvent-free liquid chromatographic technique. Separation was performed on RP-C18 stationary phase using mixed-micellar mobile phase composed of a mixture 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. The mobile phase flow rate was 1 mL min−1, and detection was carried out at a wavelength of 244 nm. We profiled the impurities that originated in mild to drastic degradation conditions. The method was then validated according to International Conference of Harmonization (ICH) guidelines within a linearity range of 5–100 μg mL−1 and applied successfully for the determination of the drug in its marketed dosage form. A brief comparison was established with reported chromatographic methods, including a greenness assessment on two new metrics (GAPI and AGREE). This study is the first to be reported as eco-friendly, solvent-free, and stability indicating LC methodology for RDS determination and impurity profiling.
Highlights
In December 2019, COVID-19 was discovered; since a pandemic infection has spread all over the world, causing patients pneumonia and acute respiratory distress syndrome that potentially progresses to death [1]
The developed method was validated according to International Conference of Harmonization (ICH) guidelines [18]
The standards were injected in triplicates and the average corresponding areas under the curve were plotted against their corresponding drug concentrations
Summary
In December 2019, COVID-19 was discovered; since a pandemic infection has spread all over the world, causing patients pneumonia and acute respiratory distress syndrome that potentially progresses to death [1]. Since the process of discovery, development and evaluation of any new active pharmaceutical ingredient (API) is tedious and requires a long time for safety and clinical profiling, older, clinically profiled antivirals were extensively tested against the new causative virus. Among these molecules, remdesivir (RDS) emerged as a promising active nucleus against the virus [1,2]. As expensive tools, they are not readily present in most of QC laboratories [6] Another electrochemical for the determination of RDS was reported [16]. The method is sustainable since it is solvent free and was assessed for greenness against recent metrics and compared to previously reported analytical methodologies in order to prove its efficiency and desirable ecological safety
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