高效液相色谱法测定癫痫患者血浆中拉莫三嗪的浓度  

Determination of plasma concentration of lamotrigine in epilepsy patients by RP-HPLC

作　　者：刘立民[1] 刘美[1] 朱旭[1] 孙亚欣[1] 何晓静[1] 邱枫[1] 肇丽梅[1] 

机构地区：[1]中国医科大学附属盛京医院药学部,辽宁沈阳110004

出　　处：《中国医院药学杂志》2013年第7期552-555,共4页Chinese Journal of Hospital Pharmacy

基　　金：辽宁省科学技术计划项目(编号:2009225020)

摘　　要：目的:建立测定血浆中拉莫三嗪浓度的高效液相色谱方法。方法:以氯唑沙宗为内标,血浆样品用乙醚萃取,采用C18柱(4.6mm×250mm,5μm)分析。流动相为乙腈-0.05mol·L-1磷酸二氢钠溶液(v/v,26.5∶73.5,pH 4.5),流速为1.0mL.min-1,检测波长220nm,柱温25℃。结果:拉莫三嗪浓度在0.5～30μg·mL-1范围内线性关系良好,r=0.9911,定量下限为0.5μg·mL-1,提取回收率在90.00%～93.75%,日内、日间RSD均<15%。25例癫痫患者拉莫三嗪血药浓度范围为0.5～10.2μg·mL-1,与推荐的拉莫三嗪有效治疗浓度相比波动较大,标准化血药浓度为0.8～5.1μg·mL-1,拉莫三嗪血药浓度与日剂量(0.5～3.8mg.kg-1.d-1)线性相关。结论:该方法简便、准确、灵敏度高、回收率及精密度高,可用于拉莫三嗪的血药浓度监测。OBJECFIVE To develop an HPLC method for the determination of lamotrigine in human plasma. METHODS With chlorzoxazone as internal standard, the plasma was extracted with diethyl ether. The analysis was conducted on a C18 column. The flow rate was 1.0 mL·min^-1 and the column temperature was 25 ℃. The detecting wavelength was set at 220 nm. The mobile phase consisted of acetonitrile-0. 05 mot·L^-1 biphosphate sodium（v/v,26. 5：73. 5,pH 4. 5）. RESULTS The linear range of lamotrigine was 0.5～30 μg·mL^-1 （r = 0. 991 1 ） and the detection limit was 0. 5μg·mL^-1 . The range of extraction recovery ratio was 90. 00% - 93.75%. The intra-and inter-day precision was both less than 15%. The concentration range of lamotrigine in 25 epilepsy patients was 0. 5 - 10. 2μg·mL^-1 , which fluctuated more widely compared with the recommended concentration. The relationship between lamotrigine plasma concentration and daily doses （0. 5 - 3.8 mg·kg^-1·d^-1 ） was linear.concentration. The relationship between lamotrigine plasma concentration and daily doses （0. 5 - 3.8 mg·kg^-1·d^-1 ） was linear. The range of the lamotrigine concentration to dose ratio was 0. 8 - 5.1 μg·mL^-1. CONCLUSION The method is simple, accurate, sensitive, which is suitable for the study of therapeutic drug concentration monitoring of lamotrigine.

关 键 词：拉莫三嗪 反相高效液相色谱法 血药浓度 

分 类 号：R927.2[医药卫生—药学]