高效液相色谱法测定人血浆中氯氮平浓度及其临床应用  

Determination of Clozapine in Human Plasma by High Performance Liquid Chromatography and its Clinical Application

作　　者：王丽霞[1] 陈志成[1] 陈清霞[2] 杨红梅 梁小丽 刘伟忠[1] 

机构地区：[1]广州医科大学附属脑科医院,广州市惠爱医院,广东广州510370 [2]中山大学附属第二医院,广东广州510120 [3]广州市妇女儿童医疗中心,广东广州510120

出　　处：《深圳中西医结合杂志》2017年第13期192-195,共4页Shenzhen Journal of Integrated Traditional Chinese and Western 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Agilent C18反相柱(150 mm×4.6 mm,5μm)为色谱柱,流动相为0.05 mol·L^(-1)醋酸铵(调p H=5.8)-乙腈-甲醇(15:15:70);流速:1.0 m L·min-1;柱温控制在40°C;灵敏度设置为0.01 AUFS。以乙酸乙酯和二氯甲烷(80:20)为提取剂。结果:氯氮平的低、中、高(100.0 ng·m L^(-1),400.0 ng·m L^(-1),800.0 ng·m L^(-1))3种浓度平均回收率分别为99.28%,98.63%,101.5%,提取回收率分别为73.13%,75.72%,77.58%;日内、日间相对标准偏差(RSD)均低于15%(n=5);分析方法的检测限为10.0 ng·m L^(-1);线性范围为50.0~1200.0 ng·m L^(-1)。线性方程:Y=0.202X-0.991,r=0.9998(n=6)。结论:本方法在测定人血浆中氯氮平浓度的实验研究有着显著的应用价值,检测结果准确度高,操作简单快速,灵敏度高,能够广泛应用于氯氮平血药浓度的检测。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 Agilent C18 column （150 mm× 4.6 mm, 5 μm）; mobile phase consisted of 0.05 mol/L ammonioum （PH 5.8）-acetonitrile-methanol （15：15：70 v/v/v）; the flow rate was 1.0 mL/ min; the detection wavelength was at 260 nm.the detection temperature was at 40 ℃ the detection wavelength was at 260 nm. The sensitivity was 0.01 AUFS. Ethyl acetate and dichloromethane （80：20 v/v） was used as extracting solvent. Results The average recoveries of clozapine in low, middle, and high concentrations （100.0, 400.0, 800.0 ng/mL） were 99.28 %, 98.63% and 101.5%, respectively. The extraction recovery were 73.13 %, 75.72 % and 77.58 %, respectively. The intra-day and inter-day variation relative standard deviation （RSD） was less than 15 %（n = 5）. The calibration curve of clozapine showed good linearity, r = 0.9998（n = 6）, over the range of 50.0 - 1200.0 ng/mL. The regression equation was Y = 0.202 X -- 0.991. The minimum detectable concentration of clozapine was 10.0 ng/mL. Conclusion This method is simple, fast, accurate and sensitive. It shows great value of clozapine detection and is worth a wide application.

关 键 词：氯氮平 血药浓度 高效液相色谱法 

分 类 号：R971.4[医药卫生—药品]