Metric analysis

Comparative greenery metric estimates for content uniformity testing of Anti-Cov-2, GS-5734 in commercial vials; Validated micellar electrokinetic chromatographic assay

This article was originally published here

J AOAC Int. January 7, 2022: qsac001. doi: 10.1093 / jaoacint / qsac001. Online ahead of print.

ABSTRACT

BACKGROUND: The antiviral drug GS-5734 “Remdesivir” is a new phosphoramidate prodrug initially developed as a treatment against Ebola virus and subsequently shown to have antiviral properties against other viruses. After clinical trials, it was the first antiviral to be approved by the United States Food and Drug Administration in 2020 to treat severe cases of the corona virus (COVID-19). The generalization of the current pandemic has prompted its rapid production and commercialization. Thus, new analytical methods must be available for its analysis quickly and easily at low cost to be applicable in all laboratories.

OBJECTIVE: In the present study, a green and economical micellar electrokinetic chromatography (MEKC) method is proposed for the analysis of remdesivir.

METHOD: A fused silica capillary (58.5 cm × 50 m id, 50 cm effective length) with 20 mM borate buffer (pH = 9) and 25 mM sodium dodecyl sulfate was used at positive potential = 30 KV at 25 ° C and detection at 245 nm.

RESULTS: Analysis for remdesivir was completed in approximately 5 minutes. The method was shown to be linear in the range 1 to 50 g / mL with a correlation coefficient r> 0.999.

CONCLUSION: The proposed MEKC method was applied for the analysis of Remdesivir in its commercial vials. The method has been validated according to the guidelines of the International Conference on Harmonization (ICH).

HIGHLIGHTS: Green chemistry has been at the center of the analytical community for the past few years. This method is considered green due to its low energy and solvent consumption without sacrificing the sensitivity or selectivity of the method. The ecological profile of the method has been assessed by different greenery rating scales to ensure that the method is environmentally friendly and can be used in the pharmaceutical industry.

PMID:35015848 | DO I:10.1093 / jaoacint / qsac001