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首页> 外文期刊>Journal of Pharmaceutical Analysis >Liquid chromatography tandem mass spectrometry method for the estimation of lamotrigine in human plasma: Application to a pharmacokinetic study
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Liquid chromatography tandem mass spectrometry method for the estimation of lamotrigine in human plasma: Application to a pharmacokinetic study

机译：液相色谱串联质谱法测定人血浆中的拉莫三嗪：在药代动力学研究中的应用

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A reliable, selective and sensitive liquid chromatography tandem mass spectrometry method was developed and validated for the quantification of lamotrigine in human plasma using lamotrigine- 13 C3, d3 as an internal standard. Analyte and internal standard were extracted from human plasma by solid-phase extraction and detected in positive ion mode by tandem mass spectrometry with electrospray ionization (ESI) interface. Chromatographic separation was performed on a Chromolith ? SpeedROD; RP-18e column (50?4.6mm i.d.) using acetonitrile: 5±0.1mM ammonium formate solution (90:10, v/v) as the mobile phase at a flow rate of 0.500mL/min. The calibration curves were linear over the range of 5.02–1226.47ng/mL with the lower limit of quantitation validated at 5.02ng/mL. The analytes were found stable in human plasma through three freeze (?20°C)-thaw (ice-cold water bath) cycles and under storage on bench-top in ice-cold water bath for at least 6.8h, and also in the mobile phase at 10°C for at least 57h. The method has shown good reproducibility, as the intra- and inter-day precisions were within 3.0%, while the accuracies were within ±6.0% of nominal values. The validated LC–MS/MS method was applied for the evaluation of pharmacokinetic and bioequivalence parameters of lamotrigine after an oral administration of 50mg lamotrigine tablet to thirty-two healthy adult male volunteers.
机译：建立了可靠，选择性和灵敏的液相色谱串联质谱法，并以拉莫三嗪13 C3，d3作为内标物对人血浆中拉莫三嗪的定量进行了验证。通过固相萃取从人血浆中提取分析物和内标物，并通过带有电喷雾电离（ESI）接口的串联质谱法在正离子模式下进行检测。色谱分离是在Chromolith？上进行的。 SpeedROD; RP-18e色谱柱（内径50？4.6mm），使用乙腈：5±0.1mM甲酸铵溶液（90：10，v / v）作为流动相，流速为0.500mL / min。校准曲线在5.02–1226.47ng / mL范围内呈线性，定量下限为5.02ng / mL。通过三个冷冻（？20°C）融化（冰冷水浴）循环后发现分析物在人血浆中稳定，并在台式桌上保存在冰冷水浴中至少6.8h，以及在流动相在10°C持续至少57h。该方法具有良好的重现性，因为日内和日间精度在3.0％以内，而精度在标称值的±6.0％以内。经验证的LC-MS / MS方法用于对32名健康成年男性志愿者口服50 mg拉莫三嗪片后评估拉莫三嗪的药代动力学和生物等效性参数。

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