Abstract
The SARS-CoV-2 coronavirus pandemic also referred to as COVID-19 is a severe respiratory illness. Molnupiravir (Moln) is a frequently prescribed antiviral medication used in the treatment regimen for mild to moderate cases of COVID-19. Since medications might experience chemical deterioration over time it is crucial to create a stability-indicating technique to evaluate the drug's stability. This study presents the development and validation of a novel stability-indicating approach employing reversed-phase high-performance liquid chromatography. The purpose of this method is to accurately quantify Moln in the presence of its degradation products. The technique was determined to be linear throughout the concentration range of 10–200 μg/mL. It exhibited precision accuracy and specificity. Moln was shown to be susceptible to oxidative acidic and basic hydrolysis. The proposed structure of the degradants was determined using LC-MS. The degradation kinetics were examined revealing that both acidic and oxidative hydrolysis conditions adhere to first-order kinetics. The sulforhodamine B (SRB) test was used to assess the impact of these degradants on Human skin fibroblast cell. The method was assessed using four green metric scales; National environmental metric index (NEMI) Analytical-ECO scale Green Analytical Procedure Index (GAPI) and Analytical GREEnness Metric Approach (AGREE); and it was determined to be ecologically friendly.
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