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UPLC-MS/MS method for the simultaneous quantification of bictegravir and 13 others antiretroviral drugs plus cobicistat and ritonavir boosters in human plasma.
Journal of Pharmaceutical and Biomedical Analysis ( IF 3.1 ) Pub Date : 2019-12-24 , DOI: 10.1016/j.jpba.2019.113057
Hélène Gouget 1 , Gaëlle Noé 2 , Aurélie Barrail-Tran 3 , Valérie Furlan 2
Affiliation  

A sensitive and rapid ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method has been developed and validated for 14 antiretroviral drugs and 2 boosters in human plasma. Plasma (100 μL) was precipitated with a solution of acetonitrile containing labelled internal standards. The compounds were separated with a total chromatic run time of 6 min using an Acclaim TM RSLC 120 C18 column (2.1 × 100 mm, 2.2 μm). The method was fully validated according to the European Medecines Agency guidelines. Linearity of all analytes concentrations was validated up to 5000 ng/mL. Lower limits of quantification were ranged from 2.5 ng/mL to 10 ng/mL according to compounds. Intra-day and inter-day precision ranged from 0.2% to 8.9% and accuracies were below 13%. This UPLC-MS/MS method can be applied to clinical pharmacology research and therapeutic drug monitoring in patients living with HIV.

中文翻译:

UPLC-MS/MS 方法用于同时定量人血浆中的比替拉韦和其他 13 种抗逆转录病毒药物以及考比司他和利托那韦增强剂。

已开发出一种灵敏、快速的超高效液相色谱-串联质谱 (UPLC-MS/MS) 方法并对其进行了验证,可用于人血浆中的 14 种抗逆转录病毒药物和 2 种增强剂。血浆 (100 μL) 用含有标记内标的乙腈溶液沉淀。使用 Acclaim TM RSLC 120 C18 色谱柱(2.1 × 100 mm,2.2 μm)以 6 分钟的总色谱运行时间分离化合物。该方法已根据欧洲药品管理局的指南进行了充分验证。所有分析物浓度的线性经验证高达 5000 ng/mL。根据化合物的不同,定量的下限范围为 2.5 ng/mL 至 10 ng/mL。日内和日间精密度介于 0.2% 至 8.9% 之间,准确度低于 13%。
更新日期:2019-12-25
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