高效液相色谱法测定人血浆中拉莫三嗪浓度

Determination of the Concentration of Lamotrigine in Human Plasma by HPLC

目的建立高效液相色谱法测定人血浆中拉莫三嗪的浓度。方法以Diamonsil TM C18反相柱（150mm×4.6mm,5μm）为色谱柱,流动相为0.03mol·L^-1醋酸铵-甲醇（58∶42）;流速：1.0m L·min^-1;柱温：30℃;检测波长：310nm。以乙酸乙酯为提取剂。结果拉莫三嗪浓度在0.5~24.0μg·m L^-1范围内,峰面积与浓度线性关系良好;拉莫三嗪的低、中、高浓度（1.0,8.0,20.0μg·m L^-1）相对平均回收率大于95%;提取回收率大于75%。日内、日间RSD均低于10%（n=5）。分析方法的检测限0.1μg·m L^-1;拉莫三嗪曲线回归方程为：Y=0.0899X＋0.0215,r=0.9989（n=7）;结论该方法灵敏、准确、简单、快速,能够满足体内药物分析的要求。

OBJECTIVE To establish a method for determining the concentration of lamotrigine in human plasma by HPLC. METHODS The drug from plasma was analyzed in a reverse phase HPLC system C18column（150 mm × 4. 6mm,5μm）; mobile phase consisted of 0. 03mol·L^-1ammonium acetate-methanol（58 ∶ 42）; the flow rate was1. 0m L · min^-1; the detection wavelength was at 310 nm. Ethyl acetate was used as extracting solvent. RESULTS The peak area and concentration of Lamotrigine in 0. 5 ~ 24. 0μg·m L^-1has good linearity. The average recoveries of lamotrigne in low,middle and high concentrations（1. 0,8. 0,20. 0μg·m L^-1） were over 95%respectively; the extraction recovery over 75%. The intra-day and inter-day variation（RSD） was less than 10%（n =5）. The minimum detectable concentration of lamotrigne was 0. 1μg · m L^-1. The regression equation was Y =0. 0899 X ＋ 0. 0215. r = 0. 9989（n = 7）. CONCLUSION The method is sensitive,accurate,simple,fast. It is suitable for deter mination of drug analysis.