高效液相色谱法测定人血浆中氨磺必利的浓度

Determination of amisulpride in plasma by HPLC with UV detection

目的:建立测定人血浆中氨磺必利浓度的高效液相色谱法。方法:以DiamonsilTMC18(150mm×4.6mm,5μm)为色谱柱,流动相为0.03mol.L-1磷酸二氢钾(调pH6.4)-乙腈(82∶18),流速为1.0mL.min-1,柱温40℃,检测波长为275nm。以醋酸乙酯-二氯甲烷(80∶20)为提取剂。结果:氨磺必利1000.0,400.0,10.0μg.L-13种质量浓度平均回收率分别为97.63%,98.71%,100.29%,日内、日间差RSD均低于8%(n=5);分析方法的最低检测浓度为10.0μg.L-1;线性范围10.0～1000.0μg.L-1。回归方程C=136.03F-3.25,r=0.9996(n=9)。结论:本法灵敏、准确、简单、快速,可用于临床血药浓度监测和药动学研究。

OBJECTIVE To establish a method for determining the plasma concentration of amisulpride by HPLC. METHODS Amisulpride was extracted with diethyl ether. The residues were analyzed by a reverse phase HPLC system with Diamonsil Ca8 column （150 mm×4. 6 mm,5μm）, the mobile phase consisted of 0. 03 mol·L^-1 Postassium dihydrogen phosphate（pH6. 4）-acetonitrile （82 ： 18） the detection wavelength was at 275 nm. RESULTS The average recoveries of amisulpride were 97. 63 %, 98. 71% and 100. 29%, respectively. The within-day and between-day precision of variation was less than 8 %. The calibration curves of arnisulpride ranged from 10. 0-1 000. 0μg·L^-1 had good linearity,r= 0. 999 6（n= 9）. The limits of quantitation for amisulpride was 10.0 μg·L^-1. CONCLUSION The method provides a sensitive, accurate, precise and reliable analytical procedure for clinical monitoring of amisulpride in plasma and its pharmacokinetic studies.