Analytical Chemistry Department, Faculty of Pharmacy, Minia University, Minia, Egypt.
Pharmaceutical Chemistry Department, Faculty of Pharmacy, Nahda University, Beni-Suef, Egypt.
Luminescence. 2022 Jul;37(7):1192-1199. doi: 10.1002/bio.4274. Epub 2022 May 22.
Following the sudden widespread of the novel coronavirus (COVID-19) which first appeared in Wuhan city. Remdesivir (REM) was the first medicine licensed by the US Food and Drug Administration (FDA) for COVID-19 infected hospitalized patients. Hence, there was an urgent demand for the optimization of efficient selective and sensitive methods to be developed for the determination of REM in pharmaceuticals as well as biological samples. A sensitive and simple green spectrofluorimetric method has been developed to determine REM in pharmaceutical formulation, in addition to, spiked human plasma. The technique involves measuring the native fluorescence of REM in distilled water at 410 nm followed by excitation at 241 nm, giving a linear relationship over the range 50.00-500.00 ng/mL, and then improving the sensitivity of REM through micellar formation using 2.00% w/v sodium dodecyl sulfate (SDS). A linear relationship has been obtained over the range 10.00-350.00 ng/mL having detection and quantitation limits of 2.34 and 7.10 ng/mL, respectively. Different analytical parameters have been carefully studied. A validation study has been conducted successfully in accordance with the FDA and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. The developed methods' greenness was assessed utilizing a greenness profile and analytical eco-scale standards. Both methods were discovered to be environmentally friendly and could be successfully used for the determination of the studied drugs in pharmaceutical formulation and human plasma with good accuracy and high precision. As a result, the developed spectrofluorimetric methods could be ideally suited for determination of REM in quality control and medicinal laboratories.
新型冠状病毒(COVID-19)最初出现在武汉市后突然广泛传播。瑞德西韦(REM)是美国食品和药物管理局(FDA)首次批准用于治疗 COVID-19 感染住院患者的药物。因此,迫切需要优化高效的选择性和敏感性方法,以用于药物和生物样本中 REM 的测定。已经开发了一种灵敏且简单的绿色分光荧光法来测定药物制剂以及加标人血浆中的 REM。该技术涉及在蒸馏水(REM 在其中发出固有荧光)中于 410nm 处测量 REM 的荧光,然后在 241nm 处激发,在 50.00-500.00ng/mL 范围内给出线性关系,然后通过使用 2.00%w/v 十二烷基硫酸钠(SDS)形成胶束来提高 REM 的灵敏度。在 10.00-350.00ng/mL 范围内获得了线性关系,检测限和定量限分别为 2.34 和 7.10ng/mL。仔细研究了不同的分析参数。已根据 FDA 和国际人用药物技术要求协调理事会(ICH)指南成功进行了验证研究。利用绿色分析档案和分析生态标准评估了开发方法的绿色性。发现这两种方法均具有环保性,可以成功地用于药物制剂和人血浆中研究药物的测定,具有良好的准确性和高精度。因此,所开发的分光荧光法非常适合于质量控制和药物实验室中 REM 的测定。