高效液相色谱法测定人血浆中氯氮平浓度  

Concentrations Determination of Clozapine in Human Plasma by HPLC

作　　者：吴岚 朱军[2] 刘文宪[3] 刘伟忠[3] 王华成[3] 

机构地区：[1]湖南省血防所附属湘岳医院药剂科,岳阳414000 [2]中山大学附属第二医院药学部,广州510120 [3]广州市脑科医院国家药品临床研究基地,广州510370

出　　处：《医药导报》2008年第4期386-388,共3页Herald of Medicine

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（25：75）；流速0．8mL·min^-1，柱温40℃，检测波长254nm。以醋酸乙酯与二氯甲烷（80：20）为提取剂。结果氯氮平的高、中、低（1000．0，400．0，10．0ng·mL^-1）3种浓度平均回收率分别为98．28％，97．63％，101．41％，日内、日间精密度RSD均〈7％（n=5）；分析方法的检测限为5．0ng·mL^-1；线性范围为10．0～1000．0ng·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 concentration of clozapine in human plasma by HPLC. Methods The drug from plasma was analyzed in a reverse phase HPLC system Cls column （ 150 mm×4.6mm, 5μm） ; mobile phase consisted of 0.03 mol·L^-1ammonioum-methanol （25：75） ; the flow rate was 0.8 mL·min^-1 ; the detection wavelength was at 254 nm. Ethyl acetate and dichloromethane（80：20） was used as extracting solvent. Results The average recoveries of clozapine in high, middle and low concentrations（ 1000.0,400.0, 10.0 ng·mL^-1 ） were 98.28% , 97.63% and 101.41%, respectively. The intra-day and inter-day variation （RSD） was less than 7% （n=5）. The calibration curve of clozapine showed good linearity, r =0.999 7 （ n = 10）, over the range of 10.0 - 1 000.0 ng·mL^-1. The regression equation was C = 25.69F ＋ 3.47, r = 0. 999 7 （ n = 10）. The minimum detectable concentration of clozapine was 5.0 ng·mL^-1. Conclusion The method is sensitive, accurate, easy and quick, which can be used for clinical drug monitoring and pharmacokinetics studies.

关 键 词：氯氮平 血药浓度 色谱法 高效液相 

分 类 号：R971.4[医药卫生—药品] R927.2[医药卫生—药学]