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首页> 外文期刊>Journal of Pharmaceutical Analysis >Simultaneous determination of telmisartan and amlodipine in human plasma by LC–MS/MS and its application in a human pharmacokinetic study
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Simultaneous determination of telmisartan and amlodipine in human plasma by LC–MS/MS and its application in a human pharmacokinetic study

机译：LC-MS / MS同时测定人血浆中替米沙坦和氨氯地平的含量及其在人体药代动力学研究中的应用

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摘要

A rapid and sensitive liquid chromatography–tandem mass spectrometric (LC–MS/MS) assay method has been developed and fully validated for the simultaneous quantification of telmisartan and amlodipine in human plasma. Carbamazepine was used as an internal standard. Analytes and the internal standard were extracted from human plasma by solid-phase extraction technique using Waters Oasis ? HLB 1cm 3 (30mg) extraction cartridge. The reconstituted samples were chromatographed on a Hypurity advance C 18 column (50mm×4.6mm, 5μm) using a mixture of acetonitrile–5mM ammonium acetate buffer (pH-4.0) (50:50, v/v) as the mobile phase at a flow rate of 0.8mL/min. The calibration curve obtained was linear ( r ≥0.99) over the concentration range of 2.01–400.06ng/mL for telmisartan and 0.05–10.01ng/mL for amlodipine. Method validation was performed as per FDA guidelines and the results met the acceptance criteria. A run time of 2.5min for each sample made it possible to analyze more than 400 human plasma samples per day. The proposed method was found to be applicable to clinical studies.
机译：已经开发了一种快速灵敏的液相色谱-串联质谱（LC-MS / MS）测定方法，并已完全验证了可同时定量测定人血浆中替米沙坦和氨氯地平的含量。卡马西平用作内标。使用沃特世绿洲®固相萃取技术从人血浆中萃取分析物和内标。 HLB 1cm 3（30mg）萃取柱。重构的样品在Hypurity Advance C 18色谱柱（50mm×4.6mm，5μm）上进行色谱分离，使用乙腈–5mM醋酸铵缓冲液（pH-4.0）（50:50，v / v）的流动相。流速为0.8mL / min。替米沙坦的浓度范围为2.01–400.06ng / mL，氨氯地平的浓度范围为0.05–10.01ng / mL，所获得的校准曲线为线性（r≥0.99）。根据FDA指南进行方法验证，结果符合接受标准。每个样品的运行时间为2.5分钟，使得每天可以分析400多个人体血浆样品。发现提出的方法适用于临床研究。

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