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首页> 外文OA文献 >A validated liquid chromatography tandem mass spectrometry method for quantification of erlotinib, OSI-420 and didesmethyl erlotinib and semi-quantification of erlotinib metabolites in human plasma
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A validated liquid chromatography tandem mass spectrometry method for quantification of erlotinib, OSI-420 and didesmethyl erlotinib and semi-quantification of erlotinib metabolites in human plasma

机译：经验证的液相色谱串联质谱法定量人体血浆中的厄洛替尼，OSI-420和二苯甲基甲基厄洛替尼以及半定量厄洛替尼代谢物

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A liquid chromatography tandem mass spectrometry method was developed and validated for quantification of erlotinib and its metabolites in human plasma. The method is suitable for therapeutic drug monitoring and pharmacokinetic studies. The substances were extracted using protein precipitation, separated on a BEH XBridge C18 column (100 x 2.1 mm, 1.7 mu m) by gradient elution at 0.7 mL/min of acetonitrile and 5 mM ammonium acetate. The concentration was determined using a Waters Xevo triple quadrupole mass spectrometer in a multi reaction monitoring mode. The total run time was 7 min. Deuterated erlotinib and OSI-597 were used as internal standard for erlotinib and its metabolites, respectively. Erlotinib, OSI-420 and didesmethyl erlotinib were quantified in the concentration range 25-5000 ng/mL, 0.5-500 ng/mL and 0.15-10 ng/mL, respectively. Precision and accuracy was less than14% except for OSI-420 at LLOQ (17%). Extraction recovery was above 89%, 99% and 89% for erlotinib, OSI-420 and didesmethyl erlotinib, respectively. The human liver microsomes generated 14 metabolites, three of them not previously reported. Twelve metabolites were measured semi-quantitatively and validated with respect to selectivity, precision and stability. (C) 2014 Elsevier B.V. All rights reserved.
机译：建立了液相色谱串联质谱法，并验证了其在人体血浆中定量厄洛替尼及其代谢产物的有效性。该方法适用于治疗药物监测和药代动力学研究。使用蛋白质沉淀提取物质，在BEH XBridge C18色谱柱（100 x 2.1 mm，1.7μm）上，通过以0.7 mL / min的乙腈和5 mM乙酸铵进行梯度洗脱，进行分离。使用Waters Xevo三重四极杆质谱仪在多反应监测模式下确定浓度。总运行时间为7分钟。氘代厄洛替尼和OSI-597分别用作厄洛替尼及其代谢物的内标。厄洛替尼，OSI-420和二羟甲基厄洛替尼的浓度范围分别为25-5000 ng / mL，0.5-500 ng / mL和0.15-10 ng / mL。除了OSL-420在LLOQ（17％）以外，精度和准确度均低于14％。厄洛替尼，OSI-420和二羟甲基厄洛替尼的提取回收率分别高于89％，99％和89％。人肝微粒体产生14种代谢产物，其中3种以前没有报道。半定量测量了十二种代谢物，并就选择性，精密度和稳定性进行了验证。 （C）2014 Elsevier B.V.保留所有权利。

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