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首页> 外文期刊>Journal of Chromatographic Science >A Sensitive and Rapid LC-MS-MS Method for Simultaneous Determination of Propafenone and Its Active Metabolite 5-Hydroxypropafenone in Human Plasma and Its Application in a Pharmacokinetic Study
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A Sensitive and Rapid LC-MS-MS Method for Simultaneous Determination of Propafenone and Its Active Metabolite 5-Hydroxypropafenone in Human Plasma and Its Application in a Pharmacokinetic Study

机译：一种敏感和快速的LC-MS-MS-MS方法，用于同时测定人血浆中丙酮酮及其活性代谢物5-羟基丙酮及其在药代动力学研究中的应用

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摘要

A simple and rapid high-performance liquid chromatography tandem mass spectrometry method for the determination of propafenone (PPF) and its active metabolite 5-hydroxypropafenone (5-OHP) in human plasma was developed and validated. This new method was linear and allowed simultaneous quantification of PPF and 5-OHP at a lower level of 0.5 ng/mL. The aliquot of 200 mu L plasma sample was simply treated with 4-fold methanol to deproteinize the plasma. The chromatographic separation was achieved on a Hedera ODS-2C(18) analytical column with the mobile phase of methanol and 5mM ammonium acetate solution containing 0.2% formic acid (pH 3.2) (68: 32, v/v) at a flow rate of 0.4 mL/min. Quantitation of the analytes was achieved by multiple reaction monitoring under positive ionization mode. The method was successfully applied to a pharmacokinetic study of PPF and 5-OHP in healthy Chinese volunteers. After oral administration of a single dose of 425 mg PPF hydrochloride sustained-release capsule, the maximum peak plasma concentration (C-max) of PPF was 210.9 +/- 141.9 ng/mL with a T-max of 6 +/- 1 h, the C-max of 5-OHP was 129.6 +/- 65.4 ng/mL with a Tmax of 7 +/- 2 h. The area under plasma concentration-time curve (AUC(0-36)) of PPF was 1610 +/- 1309 ng . h/mL with a t(1/2) of 4.6 +/- 1.1 h, the AUC(0-36) of 5-OHP was 1446 +/- 754 ng . h/mL with a t(1/2) of 7.6 +/- 1.6 h.
机译：开发并验证了一种简单快捷地高效的高效液相色谱串联质谱法，用于测定丙酮酮（PPF）及其活性代谢物5-羟基丙酮（5-OHP）中的人血浆中的验证。这种新方法是线性的，并允许在较低水平的0.5ng / ml的ppf和5-OHP的同时定量。用4倍甲醇处理200μl血浆样品的等分试样，以剥夺血浆。在HEDERA ODS-2C（18）分析柱上实现了色谱分离，其具有甲醇的流动相和5mM乙酸铵溶液，含有0.2％甲酸（pH3.2）（68：32，v / v）的流速0.4 ml / min。通过在正电离模式下进行多重反应监测来实现分析物的定量。该方法已成功应用于PPF和5 ohp在健康的中国志愿者中的药代动力学研究。口服单剂量425mg PPF盐酸盐持续释放胶囊后，PPF的最大峰血浆浓度（C-MAX）为210.9 +/- 141.9ng / ml，T-MAX为6 +/- 1小时，5-OHP的C-MAX为129.6 +/- 65.4 ng / ml，TMAX为7 +/- 2小时。 PPF的血浆浓度 - 时间曲线（AUC（0-36））下的该区域为1610 +/- 1309 ng。 H / ml具有4.6 +/- 1.1h的T（1/2），5-OHP的AUC（0-36）为1446 +/- 754 ng。 H / ml具有7.6 +/- 1.6小时的T（1/2）。

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    Chi Zhiyan; Liu Ruijuan; Li Ya; Wang Keli; Shu Chang; Ding Li;

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    China Pharmaceut Univ Dept Pharmaceut Anal 24 Tongjiaxiang Nanjing 210009 Jiangsu Peoples R China;

    China Pharmaceut Univ Dept Pharmaceut Anal 24 Tongjiaxiang Nanjing 210009 Jiangsu Peoples R China;

    China Pharmaceut Univ Dept Pharmaceut Anal 24 Tongjiaxiang Nanjing 210009 Jiangsu Peoples R China;

    China Pharmaceut Univ Dept Pharmaceut Anal 24 Tongjiaxiang Nanjing 210009 Jiangsu Peoples R China;

    China Pharmaceut Univ Dept Pharmaceut Anal 24 Tongjiaxiang Nanjing 210009 Jiangsu Peoples R China;

    China Pharmaceut Univ Dept Pharmaceut Anal 24 Tongjiaxiang Nanjing 210009 Jiangsu Peoples R China;

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  • 正文语种 eng
  • 中图分类 分析化学;
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