Abstract
The aim of this study was to develop and validate a dissolution test for favipiravir release in a tablet dosage form using ultra-high performance liquid chromatography (UHPLC). The dissolution method was developed by testing the solubility of favipiravir in media with different pH values. The results demonstrated that the best dissolution was achieved in phosphate buffer with a pH of 6.8. The amount of favipiravir that was released was about 100% after 30 min. The UHPLC method presented linearity (R = 1.000) in the concentration range of 0.044–0.44 mg/mL. The recovery parameter that was achieved ranged from 102.5% to 104.2%. The system suitability, repeatability, and intermediate precision RSD% results were found to be 0.36%, 1.99%, and 2.49%, respectively. In addition to these parameters and results, an F-test was performed using the Minitab 18 Statistical Software program for the intermediate precision and repeatability results. The standard and sample solutions were found to be stable for 2 days in their respective dissolution medium. This analytical method was also found to be selective for favipiravir. In conclusion, a simple and feasible dissolution method with a short run time of 2.5 min was developed and validated successfully. The obtained results demonstrated that the dissolution test developed here is adequate for its purpose and can be applied as the dissolution method for favipiravir in film-coated tablets for release analyses.
Highlights
COVID-19, known by its full name, coronavirus 2019, is an infectious respiratory illness that affects many people, which is caused by Severe Acute Respiratory SyndromeCoronavirus 2 (SARS-CoV-2)
Over the past few months, clinical studies have been conducted around the world to evaluate the effectiveness of favipiravir for the management of COVID-19 [9]
The most suitable dissolution medium was selected as phosphate buffer with pH 6.8 based on the solubility studies as quality control (QC) medium
Summary
COVID-19, known by its full name, coronavirus 2019, is an infectious respiratory illness that affects many people, which is caused by Severe Acute Respiratory SyndromeCoronavirus 2 (SARS-CoV-2). A specific and effective drug against COVID-19 has not yet been discovered, and no specific drug has been approved for its treatment [2]. Various antiviral drugs are being researched to treat COVID-19, and some are being used in clinical trials [3]. It has been shown to have a healing effect that can be observed within a short time despite having severe side effects. It is not yet approved as the main anti-viral agent for COVID-19, favipiravir is considered a potential candidate drug [5,6]. Over the past few months, clinical studies have been conducted around the world to evaluate the effectiveness of favipiravir for the management of COVID-19 [9]
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