HPLC法测定癫痫患者血清中拉莫三嗪质量浓度

目的建立测定癫痫患者血清中拉莫三嗪质量浓度的HPLC法。方法色谱柱为Agilent TC-C18柱(250mm×4.6mm,5μm);流动相为乙腈-10mmol·L~(-1)磷酸二氢钾(35∶65);流速为1.0mL·min~(-1);紫外检测波长为305nm;进样量为20μL;柱温为室温。内标物为非那西丁,血样采用甲醇沉淀蛋白法进行处理。结果拉莫三嗪血药质量浓度在0.5~40mg·L~(-1)范围内线性关系良好(r=0.999 8),最低检测质量浓度为50μg·L~(-1);方法回收率为94.84%~102.17%;绝对回收率为85.87%~92.86%;日内、日间精密度RSD值均<8%;血清样品在-20℃冻存3个月稳定,储备液冷藏保存12个月稳定。结论该法简便、灵敏、准确、稳定,适用于拉莫三嗪治疗药物质量浓度监测及药动学研究。

Determination of lamotrigine concentration in epilepsy patients serum by HPLC

Objective To develop an HPLC method for the mass concentration determination of lamotrigine in epilepsy patients ser-um .Methods The separation was performed on Agilent TC-C18 (250 mm × 4 .6 mm ,5 μm) with mobile phase consisted of acetoni-trile-10 mmol · L -1 potassium dihydrogen phosphate (35:65) at a flow rate of 1 .0 mL · min-1 .The detection wavelength was set at 305 nm and the injection volume was 20 μL .The column temperature was set at room temperature with phenacetin as internal standard .The serum samples were extracted by protein precipitation with methanol .Results Good linearity was obtained within 0.5-40 mg · L -1 (r=0 .9998) .The limit of detection was 50μg · L -1 and the recoveries were ranged from 94 .84% to 102 .17% . The absolute recoveries were 85 .87%-92 .86% .The RSD of intra-day and inter-day precision were less than 8% .Serum samples were stable for 3 months at -20 ℃ ,the store solution of lamotrigine was stable for a year at 2-8 ℃ .Conclusion This method is simple ,sensitive ,accurate and stable ,which could be used for lamotrigine therapeutic drug monitoring and pharmacokinetic study .