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学科主题临床医学
Simultaneous quantification of EVT201, a novel partial positive allosteric GABA(A) receptor modulator, and its two metabolites in human plasma by UHPLC/MS/MS
Zhang, Xianhua1; Zhou, Congya1; Zhang, Yuanyuan1; Zhu, Shuangpeng2; Cai, Xiaofeng2; Pan, Chunmiao2; Wang, Chuanzhen2; Zhai, Suodi1; Yang, Li1
通讯作者Yang, Li(1)
关键词UHPLC-MS/MS EVT201 Ro46-1927 Rol 8-5528 Human plasma
刊名JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
2018-09-10
DOI10.1016/j.jpba.2018.06.001
159页:282-290
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Chemistry, Analytical ; Pharmacology & Pharmacy
研究领域[WOS]Chemistry ; Pharmacology & Pharmacy
关键词[WOS]LC-MS/MS ; WHOLE-BLOOD ; BENZODIAZEPINES ; EVT-201 ; DRUGS ; SERUM
英文摘要

A sensitive, accurate and rapid UHPLC-MS/MS method was developed and validated for the simultaneous determination of EVT201 and its two metabolites, Ro46-1927 and Ro18-5528, in human plasma. IN-EVT201 was used as the internal standard (IS). Plasma samples were extracted using ethyl acetate after being alkalized with saturated sodium carbonate solution. Chromatographic separation was carried out on an Acquity BEH C18 column (2.1 x 50 mm, 1.7 mu m) with a gradient mobile phase at a flow-rate of 0.50 mL/min. The analytical run time was 5.5 min. For mass spectrometric detection, multiple reaction monitoring (MRM) was used. The MRM ion transitions were m/z 373.2 -> 58.0 for EVT201, m/z 359.2 -> 316.1 for Ro46-1927, m/z 291.2-4 -> 274.1 for Ro18-5528 and m/z 379.3 -> 64.0 for the IS. The linear range was 0.2-200 ng/mL for each analyte, with a correlation coefficient (r) over 0.9900. The intra/inter-precision was within 7.9% and 4.5% for EVT201, 13.2% and 6.3% for Ro46-1927, 3.7% and 4.1% for Ro 18-5528. For the accuracy, the relative bias of intra-/inter-run was no more than 6.4% and 4.6% for EVT201, 9.4% and 7.9% for Ro46-1927, -6.9% and -7.5% for Ro18-5528. The validated method was successfully applied to the analysis of more than 1500 samples from a Phase I clinical trial. The incurred sample reanalysis (ISR) of 146 samples from the study was evaluated and the results met the acceptance criteria. It indicated that the method could be used for the pharmacokinetic study of EVT201. (C) 2018 Elsevier B.V. All rights reserved.

语种英语
WOS记录号WOS:000442699900033
通讯作者邮箱lilianyangli413@163.com
第一作者单位Peking Univ, Third Hosp, Dept Pharm, Beijing 100191, Peoples R China
通讯作者单位Peking Univ, Third Hosp, Dept Pharm, Beijing 100191, Peoples R China
ISSN0731-7085
引用统计
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/142976
专题北京大学第三临床医学院_药剂科
作者单位1.Peking Univ, Third Hosp, Dept Pharm, Beijing 100191, Peoples R China;
2.Zhejiang Jingxin Pharmaceut Co LTD, Shaoxing 312500, Zhejiang, Peoples R China
推荐引用方式
GB/T 7714
Zhang, Xianhua,Zhou, Congya,Zhang, Yuanyuan,et al. Simultaneous quantification of EVT201, a novel partial positive allosteric GABA(A) receptor modulator, and its two metabolites in human plasma by UHPLC/MS/MS[J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS,2018,159:282-290.
APA Zhang, Xianhua.,Zhou, Congya.,Zhang, Yuanyuan.,Zhu, Shuangpeng.,Cai, Xiaofeng.,...&Yang, Li.(2018).Simultaneous quantification of EVT201, a novel partial positive allosteric GABA(A) receptor modulator, and its two metabolites in human plasma by UHPLC/MS/MS.JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS,159,282-290.
MLA Zhang, Xianhua,et al."Simultaneous quantification of EVT201, a novel partial positive allosteric GABA(A) receptor modulator, and its two metabolites in human plasma by UHPLC/MS/MS".JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS 159(2018):282-290.
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