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目的 建立快捷、灵敏、简便的高效液相色谱法(HPLC)测定拉莫三嗪(LTG)浓度,并应用于治疗药物浓度监测和药物相互作用研究.方法 以非那西丁为内标,检测波长为240 nm,使用Xterra MS C18色谱柱(4.6 mm×150 mm,5μm)为分析柱,以醋酸乙酯 二氯甲烷-叔丁基甲醚(3:1:1)为萃取剂,流动相为甲醇:水(含20 mM醋酸铵盐)(35:65,V/V),流速为1 ml/min.结果 LTG线性范围在0.1 ～ 50 μg/ml范围内线性良好(r ＞0.999),提取回收率为77.42％～83.05％,批间批内RSD均小于10％.应用HPLC检测使用LTG的87例癫痫患者血浆样本,对日剂量和血药浓度建立简单线性回归方程进行分析,血药浓度个体间差异大,剂量决定力不强(R2 =0.340).结论 HPLC简便、灵敏,可用于临床药物监测和研究,以辅助LTG个体化治疗.

Objective To develop a simple,quick and fully validated HPLC method for determination of lamotrigine (LTG) in human plasma for therapy drug monitor.Methods Phenacetin was used as internal standard (IS).A simple liquid-liquid extraction process was employed to extract LTG and IS from human plasma which had been basified before.Chromatographic separation was performed on a Xterra MS C18 column (4.6mm × 150mm,3 μm),and the wave length of detection was 240nm.The mobile phase consisted of methanol-water(containing 20 mM ammonium acetate) (35:65,V/V).Results A linear response function was established for the range of concentrations 0.1 ～ 50μg/ml(r ＞ 0.999) for LTG.The recoveries of this method were 77.42％ ～ 83.05％ for LTG.The intraand inter-day precision values (RSD) was less than 10％.A total of 87 plasma samples of epilepsy patients had been assayed via HPLC.A linear regression was employed to explore the correlation between the dose and concentration in these patients,indicating low determination of dose factor(R2 =0.340)to concentration and wide individual variation.Conclusion HPLC had been proved to be quick,convenient,suitable for the study and therapy drug monitor to individualise patient therapy of LTG.