Comparative Greenness Metric Estimates for Content Uniformity Testing of Anti-Cov-2, GS-5734 in Commercial Vials: Validated Micellar Electrokinetic Chromatographic Assay.
| Autor: | Elonsy SM; Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Damanhour University, Beheira, Egypt., Kamal MF; Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Damanhour University, Beheira, Egypt., Hamdy MMA; Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Pharos University in Alexandria, Alexandria, Egypt., Abdel Moneim MM; Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Pharos University in Alexandria, Alexandria, Egypt. |
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| Jazyk: | angličtina |
| Zdroj: | Journal of AOAC International [J AOAC Int] 2022 Apr 27; Vol. 105 (3), pp. 739-747. |
| DOI: | 10.1093/jaoacint/qsac001 |
| Abstrakt: | Background: The antiviral drug GS-5734 remdesivir is a new phosphoramidate prodrug developed initially as a treatment for Ebola virus which then proved to have antiviral properties against other viruses. After clinical trials, it was the first antiviral to be approved by the U.S. Food and Drug Administration in 2020 to treat severe coronavirus (COVID-19) cases. The widespread current pandemic gave an urge to its fast production and marketing. Thus, new analytical methods must be available for its analysis in a fast and easy manner with low cost to be applicable in all laboratories. Objective: In the current study, a green and economic micellar electrokinetic chromatographic (MEKC) method is proposed for remdesivir analysis. Methods: A fused-silica capillary (58.5 cm × 50 μm id, 50 cm effective length) with 20 mM borate buffer (pH 9) and 25 mM sodium dodecyl sulfate was used under a positive potential of 30 kV at 25°C with detection at 245 nm. Results: Remdesivir analysis was achieved in approximately 5 min. The method proved to be linear in range of 1-50 μg/mL with correlation coefficient, r > 0.999. Conclusion: The MEKC method proposed was applied to the analysis of remdesivir in its commercial vials. The method was validated per International Conference on Harmonization guidelines. Highlights: Green chemistry has been the focus of the analytical community in the past few years. This method is considered green due to its low energy and solvent consumption without sacrificing the method's sensitivity or selectivity. The method's green profile has been assessed by different greenness assessment scales to ensure the method is eco-friendly and can be used in the pharmaceutical industry. (© The Author(s) 2022. Published by Oxford University Press on behalf of AOAC INTERNATIONAL. All rights reserved. For permissions, please email: journals.permissions@oup.com.) |
| Databáze: | MEDLINE |
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