摘要
目的建立测定人血浆中氯氮平浓度的高效液相色谱法。方法以DiamonsilTM 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(25:75);流速:0.8 ml.min-1;柱温:40°C;检测波长:254nm。以乙酸乙酯与二氯甲烷(80:20)为提取剂。结果氯氮平的高、中、低(1000.0,400.0,10.0 ng.mL-1)3种浓度平均回收率分别为105.36%,98.63%,97.46%,日内、日间差RSD均低于7%(n=5);分析方法的检测限为5.0 ng.mL-1;线性范围为10.0-1000.0 ng.mL-1。曲线方程:C=25.69F+3.47,r=0.9997(n=10)。结论:该方法灵敏、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 human plasma concentration of clozapine by HPLC. Methods： Blood plasma samples containing the drug were extracted with ethyl acetate and dichloromethane （80：20）. The extract was then analyzed in a reverse phase HPLC system （C18 column, 150mm×4.6mm, 5μm）; mobile phase consisted of 0.03mol·L-lammonioum-methanol （25：75）; the detection wavelength was at 254nm. Results： The average recoveries of clozapine in high, medium and low concentrations （1000.0, 400.0, 10.0 ng·mL-1） were 105.36%, 98.63% and 97.46%, respectively. The within-day and between-day precision of variation was less than 7%. The calibration curves of clozapine had good linearity, r= 0.9997（n=10）, over the range of 10.0-1000.0 ng-mL-1. The regression equation was C=25.69F＋3.47, r=0.9997 （n=10）. The min detectable concentration of clozapine was 5.0 ng-mL-1. Conclusion： The method provides a sensitive, accurate precise and reliable analytical procedure for clinical monitoring of clozapine in human plasma and its pharmaco-kinetics studies.
出处
《岳阳职业技术学院学报》
2007年第4期58-61,共4页
Journal of Yueyang Vocational and Technical College
