El-Fattah Mai H Abd, Sharaf Yasmine Ahmed, El-Sayed Heba M, Hassan Said A
Pharmaceutical Analytical Chemistry Department, College of Pharmaceutical Sciences and Drug Manufacturing, Misr University for Science & Technology, 6th of October City, Giza, 12566, Egypt.
Department of Analytical Chemistry, Faculty of Pharmacy, Zagazig University, Zagazig, 44519, Egypt.
Sci Rep. 2025 Jun 23;15(1):20251. doi: 10.1038/s41598-025-05198-4.
The global outbreak of the novel coronavirus (COVID-19) has highlighted the urgent need for innovative therapeutic solutions. Remdesivir (REM) was the first drug granted approval by the US FDA for treating hospitalized COVID-19 patients. A selective and sensitive derivative spectrofluorimetric method has been developed and validated for the determination of Remdesivir (REM) in presence of its Alkaline-induced degradation product (AKDP), which is also known to be its metabolite (GS-441524). The method utilized the intrinsic fluorescence properties of REM, achieving a linear response within the range of 3.0-120.0 ng/mL at 428.3 nm using first-order derivative. Methodological parameters were optimized to ensure high sensitivity, with detection and quantification limits of 1.12 and 3.67 ng/mL, respectively. This approach successfully quantified REM in pure form, intravenous infusions, and spiked human plasma. Recovery rates in plasma were satisfactory at 97.64 ± 1.87, confirming the method's suitability for therapeutic drug monitoring (TDM) in COVID-19 patients. Additionally, the environmental sustainability of the method was evaluated using GAPI, AGREE, and RGB12 metrics, underscoring its green and eco-friendly characteristics.
新型冠状病毒(COVID-19)的全球大流行凸显了对创新治疗方案的迫切需求。瑞德西韦(REM)是美国食品药品监督管理局(FDA)批准的首个用于治疗住院COVID-19患者的药物。已开发并验证了一种选择性灵敏的导数分光荧光法,用于在碱性诱导降解产物(AKDP,也已知是其代谢物GS-441524)存在的情况下测定瑞德西韦(REM)。该方法利用了REM的固有荧光特性,在428.3 nm处使用一阶导数在3.0 - 120.0 ng/mL范围内实现线性响应。对方法学参数进行了优化以确保高灵敏度,检测限和定量限分别为1.12和3.67 ng/mL。该方法成功地对纯品、静脉输液和加标人血浆中的REM进行了定量。血浆中的回收率令人满意,为97.64±1.87,证实了该方法适用于COVID-19患者的治疗药物监测(TDM)。此外,使用GAPI、AGREE和RGB12指标评估了该方法的环境可持续性,突出了其绿色环保特性。