期刊
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
卷 182, 期 -, 页码 -出版社
ELSEVIER
DOI: 10.1016/j.jpba.2020.113119
关键词
Liquid chromatography; Tandem mass spectrometry; Antiretroviral; Therapeutic drug monitoring
Therapeutic drug monitoring (TDM) is essential in the optimization of antiretroviral (ARV) treatments. In this work, we describe a new method for the simultaneous quantification of six molecules: the three novel ARV agents dolutegravir (DTG), elvitegravir (ELV) and rilpivirine (RPV), the first integrase inhibitor raltegravir (RAL) and its major metabolite the raltegravir-beta-D-glucuronide (RAL-GLU), an protease inhibitor darunavir (DRV) and its booster ritonavir (RN) in human plasma. The drugs were extracted from 100 mu l of plasma by a simple method of protein precipitation using acetonitrile. The separation was carried out on a Kinetex phehyl-hexyl column using a phase mobile composed of 55 % of water (0.05 % formic acid,v/v) and 45 % of methanol (0.05 % formic acid,v/v). The flow rate was set at 0.5 mL/min. The calibration ranged from 60 to 15000 ng/mL for DRV, from 20 to 5000 ng/mL for DTG and ELV, from 10 to 2500 ng/mL for RAL, RAL-GLU, RTV and RPV. The proposed method was validated with a good precision (inter- and intra-day CV% inferior to 12.3 %) and a good accuracy (inter- and intra-day bias between -9.9 % and 10 %) for all the analytes. The proposed method is simple, reliable and suitable for therapeutic drug monitoring (TDM) and for pharmacokinetics studies. (C) 2020 Elsevier B.V. All rights reserved.
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