Pharmaceutical Chemistry Department, Faculty of Pharmacy, Delta University for Science and Technology, Gamasa, 35712, Egypt.
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Mansoura University, Mansoura, 35516, Egypt.
Sci Rep. 2024 May 1;14(1):10025. doi: 10.1038/s41598-024-56923-4.
The coronavirus-2 has led to a global pandemic of COVID-19 with an outbreak of severe acute respiratory syndrome leading to worldwide quarantine measures and a rise in death rates. The objective of this study is to propose a green, sensitive, and selective densitometric method to simultaneously quantify remdesivir (REM) in the presence of the co-administered drug linezolid (LNZ) and rivaroxaban (RIV) in spiked human plasma. TLC silica gel aluminum plates 60 F254 were used as the stationary phase, and the mobile phase was composed of dichloromethane (DCM): acetone (8.5:1.5, v/v) with densitometric detection at 254 nm. Well-resolved peaks have been observed with retardation factors (R) of 0.23, 0.53, and 0.72 for REM, LNZ, and RIV, respectively. A validation study was conducted according to ICH Q2 (R1) Guidelines. The method was rectilinear over the concentration ranges of 0.2-5.5 μg/band, 0.2-4.5 μg/band and 0.1-3.0 μg/band for REM, LNZ and RIV, respectively. The sensitivities of REM, LIN, and RIV were outstanding, with quantitation limits of 128.8, 50.5, and 55.8 ng/band, respectively. The approach has shown outstanding recoveries ranging from 98.3 to 101.2% when applied to pharmaceutical formulations and spiked human plasma. The method's greenness was assessed using Analytical Eco-scale, GAPI, and AGREE metrics.
新型冠状病毒导致了 COVID-19 的全球大流行,严重急性呼吸系统综合征的爆发导致了全球范围的隔离措施和死亡率的上升。本研究的目的是提出一种绿色、灵敏和选择性的密度测定法,以同时定量检测人血浆中添加的药物雷米昔韦(REM)、利奈唑胺(LNZ)和利伐沙班(RIV)。TLC 硅胶 60 F254 板被用作固定相,流动相由二氯甲烷(DCM)和丙酮(8.5:1.5,v/v)组成,并用 254nm 进行密度检测。已观察到分离度良好的峰,其滞后因子(R)分别为 REM、LNZ 和 RIV 的 0.23、0.53 和 0.72。根据 ICH Q2(R1)指南进行了验证研究。该方法在 REM、LNZ 和 RIV 的浓度范围为 0.2-5.5μg/band、0.2-4.5μg/band 和 0.1-3.0μg/band 时呈线性关系。REM、LIN 和 RIV 的灵敏度非常高,定量限分别为 128.8、50.5 和 55.8ng/band。该方法应用于药物制剂和添加人血浆时,回收率高达 98.3-101.2%。使用分析生态标度、GAPI 和 AGREE 指标评估了该方法的绿色性。