Noureldeen Deena A M, Boushra John M, Lashien Adel S, Hakiem Ahmed F Abdel, Attia Tamer Z
Analytical Chemistry Department, Faculty of Pharmacy, Minia University, Minia 61519, Egypt.
Pharmaceutical Chemistry Department, Faculty of Pharmacy, Nahda University, Beni-Suef 62521, Egypt.
Microchem J. 2022 Mar;174:107101. doi: 10.1016/j.microc.2021.107101. Epub 2021 Dec 18.
A great demand for discovering new therapeutic solutions has been considered all over the world for managing the rapidly progressing COVID-19 pandemic. Remdesivir (REM) and Favipiravir (FAV) are introduced as promising newly developed antiviral agents against the corona virus as evidenced by the clinical findings. Hence, the optimization of an analytical method for their simultaneous determination acquires potential importance in quality control labs and further confirmatory investigations. Herein, a green, sensitive, and selective densitometric method has been proposed and validated for determination of REM and FAV in pharmaceutical formulations and spiked human plasma on normal phase TLC plates. A solvent mixture of ethyl acetate-methanol-ammonia (8:2:0.2 by volume) has been chosen as developing mobile phase system. Well resolved spots have been detected at 235 nm with retardation factors (R) of 0.18 and 0.98 for REM and FAV, respectively. A validation study has been carried out in the light of ICH guidelines. Remdesivir and FAV have shown excellent sensitivities with quantitation limits down to 0.12 and 0.07 μg/band, respectively. The developed method has been successfully applied to tablet formulations and spiked plasma with excellent recoveries ranged from 97.21 to 101.31%. The greenness of the method has been evaluated using the standards of greenness profile and Eco-Scale. It has passed the four greenness profile quadrants and achieved 80 score in Eco-Scale.
为应对迅速蔓延的新冠疫情,全球对发现新的治疗方案有着巨大需求。临床研究结果表明,瑞德西韦(REM)和法匹拉韦(FAV)作为新研发的有前景的抗冠状病毒抗病毒药物被引入。因此,优化一种同时测定它们的分析方法在质量控制实验室和进一步的验证研究中具有潜在重要性。在此,本文提出并验证了一种绿色、灵敏且选择性的密度测定法,用于测定药物制剂和加标人血浆中正常相薄层色谱板上的REM和FAV。已选择乙酸乙酯 - 甲醇 - 氨(体积比8:2:0.2)的混合溶剂作为展开流动相系统。在235 nm处检测到分离良好的斑点,REM和FAV的比移值(Rf)分别为0.18和0.98。根据国际人用药品注册技术协调会(ICH)指南进行了验证研究。瑞德西韦和FAV表现出优异的灵敏度,定量限分别低至0.12和0.07 μg/条带。所开发的方法已成功应用于片剂制剂和加标血浆,回收率优异,范围为97.21%至101.31%。已使用绿色度轮廓和生态尺度标准评估了该方法的绿色度。它通过了绿色度轮廓的四个象限,并在生态尺度上获得了80分。