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抗新冠病毒药物(GS-5734)商业安瓿瓶中含量均一性测试的比较绿色度指标估计值:经验证的胶束电动色谱分析测定法。

Comparative Greenness Metric Estimates for Content Uniformity Testing of Anti-Cov-2, GS-5734 in Commercial Vials: Validated Micellar Electrokinetic Chromatographic Assay.

机构信息

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Damanhour University, Beheira, Egypt.

Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Pharos University in Alexandria, Alexandria, Egypt.

出版信息

J AOAC Int. 2022 Apr 27;105(3):739-747. doi: 10.1093/jaoacint/qsac001.

DOI:10.1093/jaoacint/qsac001
PMID:35015848
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9383131/
Abstract

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.

摘要

背景

抗病毒药物 GS-5734 瑞德西韦最初是作为埃博拉病毒的治疗药物开发的,后来被证明对其他病毒具有抗病毒特性。经过临床试验,它是 2020 年美国食品和药物管理局批准的第一种用于治疗严重冠状病毒(COVID-19)病例的抗病毒药物。当前的大流行促使瑞德西韦快速生产和销售。因此,必须有新的分析方法能够以低成本快速、简便地进行分析,适用于所有实验室。

目的

本研究提出了一种绿色、经济的胶束电动色谱(MEKC)法用于分析瑞德西韦。

方法

使用 20mM 硼酸盐缓冲液(pH9)和 25mM 十二烷基硫酸钠的熔融石英毛细管(58.5cm×50μm id,50cm 有效长度),在 25°C 下施加 30kV 的正电势,在 245nm 处检测。

结果

瑞德西韦的分析大约需要 5 分钟。该方法在 1-50μg/mL 范围内呈线性,相关系数 r>0.999。

结论

所提出的 MEKC 方法已应用于其商业小瓶中瑞德西韦的分析。该方法已按照国际协调会议指南进行验证。

要点

绿色化学是分析化学界在过去几年中的关注焦点。由于该方法的能量和溶剂消耗低,而不牺牲方法的灵敏度或选择性,因此被认为是绿色的。该方法的绿色概况已通过不同的绿色评估标准进行评估,以确保该方法环保且可用于制药行业。

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