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Determination of apatinib and its three active metabolites by UPLC-MS/MS in a Phase IV clinical trial in NSCLC patients.

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机构: [1]Laboratory of Drug Metabolism & Pharmacokinetics, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, Guangdong, 510080, PR China [2]Department of Thoracic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, 651 Dongfeng East Road, Guangzhou, Guangdong, 510080, PR China [3]Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng East Road, Guangzhou, Guangdong, 510080, PR China [4]State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macau, 999078, PR China [5]Department of Pharmacy, Qingxi Hospital, Dongguan, Guangdong, 510080, PR China
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关键词: active metabolites • apatinib • therapeutic drug monitoring • UPLC–MS/MS

摘要:
Aim: To develop and validate a simple method using UPLC-MS/MS for determination of apatinib and its three active metabolites in a Phase IV clinical trial. Materials & methods: All compounds were separated on a Hypersil GOLD™ aQ C18 Polar Endcapped LC column (50 × 2.1 mm, 1.9 μm, Thermo) using 5 mmol/l ammonium acetate with 0.1% formic acid:acetonitrile (20:80, v/v) as the mobile phase after a rapid liquid-liquid extraction. This method was validated over the linear concentration range of 1.00-1000 ng/ml for each compound. Results: The interassay precision and accuracy were less than ±15%. The validated method was successfully applied to determine concentrations of clinical samples in non-small-cell lung cancer patients.

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出版当年[2018]版:
大类 | 3 区 生物
小类 | 3 区 生化研究方法 3 区 分析化学
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 生化研究方法 4 区 分析化学
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出版当年[2017]版:
Q2 BIOCHEMICAL RESEARCH METHODS Q2 CHEMISTRY, ANALYTICAL
最新[2023]版:
Q3 BIOCHEMICAL RESEARCH METHODS Q3 CHEMISTRY, ANALYTICAL

影响因子: 最新[2023版] 最新五年平均 出版当年[2017版] 出版当年五年平均 出版前一年[2016版] 出版后一年[2018版]

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第一作者机构: [1]Laboratory of Drug Metabolism & Pharmacokinetics, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, Guangdong, 510080, PR China
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