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建立液相色谱串联质谱(LC-MS/MS)法测定人血浆中加巴喷丁的浓度并将其应用于人体药动学研究。取血浆样品经甲醇沉淀蛋白后,以甲醇0.2%甲酸水溶液(80∶20)为流动相,用Inertsil ODS-3 C18柱(50 mm×2.1 mm ID,3μm)分离,采用电喷雾离子源,以多反应监测(MRM)方式进行正离子检测,定量分析的离子反应分别为m/z 172→m/z 154(加巴喷丁)和m/z 130→m/z 71(内标二甲双胍)。加巴喷丁线性范围为40.8～8.16×103 ng.mL 1,定量限为40.8 ng.mL 1,每个样品测试时间仅2.2 min,日内、日间精密度(RSD)均小于12%,准确度(RE)在±6.4%范围内。应用此法研究了20名健康志愿者单剂量口服加巴喷丁胶囊600 mg后的药动学特点。该方法快速、专属、灵敏、适用性强,可应用于加巴喷丁的人体药动学研究。
To establish a liquid chromatography tandem mass spectrometry (LC-MS / MS) method for the determination of gabapentin in human plasma and its application in human pharmacokinetic studies. The plasma samples were precipitated with methanol and separated on a Inertsil ODS-3 C18 column (50 mm × 2.1 mm ID, 3 μm) using methanol 0.2% formic acid in water (80:20) as the mobile phase. Electrospray ionization Multiple reaction monitoring (MRM) was used for the detection of positive ions. The ion reactions for quantitative analysis were m / z 172 → m / z 154 (gabapentin) and m / z 130 → m / z 71 (internal standard metformin), respectively. The linear range of gabapentin was 40.8 ~ 8.16 × 103 ng.mL 1, the limit of quantification was 40.8 ng.mL 1, the test time of each sample was only 2.2 min, the intra-day and inter-day RSD was less than 12%, and the accuracy (RE ) Is within ± 6.4%. This method was used to study the pharmacokinetics of 600 mg single oral gabapentin capsules in 20 healthy volunteers. The method is rapid, specific, sensitive and applicable and can be applied to human pharmacokinetic study of gabapentin.