HPLC法同时测定人血浆中舍曲林与氯氮平的浓度

Simultaneous Determination of the Concentration of Sertraline and Clozapine in Human Plasma by HPLC

目的:建立同时测定人血浆中舍曲林、氯氮平浓度的方法。方法:血浆样品以乙酸乙酯-二氯甲烷(80:20)进行提取并测定,色谱柱为DiamonsilTMC18反相柱,流动相为30mmol.L-1醋酸铵-乙腈(22:78),流速为1.0mL.min-1,柱温为40℃,检测波长为210nm。结果:舍曲林、氯氮平血药浓度分别在20.0～600.0μg.L-1、50.0～1000.0μg.L-1范围内线性关系良好(r分别为0.9986、0.9993),分析方法的检测限为10.0μg.L-1;舍曲林、氯氮平的低、中、高3种浓度平均相对回收率均>95%,提取回收率均>70%。日内、日间RSD均<10%(n=5)。结论:该方法灵敏、准确、简单、快速,可用于临床舍曲林与氯氮平血药浓度监测和药动学研究。

OBJECTIVE： To establish a method for the simultaneous determination of sertraline and clozapine concentration in human plasma. METHODS： Plasma sample was extracted by acetic ether-methylene chloride （80：20）. The determination was performed on Diamonsil^TM C18 column with mobile phase consisted of 30 mmol. L 1 ammonioum acetate-aeetonitrile （22：78） at the flow rate of 1.0 mL. min^-1. The detection wavelength was set at 210 nm and column temperature was 40 ℃. RESULTS： The linear ranges were 20.0-600.0 μg.L ^-1 for sertralin （r=0.998 6） and 50.0-1 000,0 μg.L ^-1 for clozapine （r=0.999 3）, respectively. The detection limit was 10.0 μg.L ^-1. The relative recovery rates of sertraline and clozapine in low, middle and high concentrations were all over 95% ; the extraction recoveries were more than 70%. The intra-day and inter-day RSDs were less than 10% （n=5）. CONCLUSION： The method is sensitive, accurate, simple and rapid, and it can be used for blood concentration monitoring and phar- macokinetics study of sertraline and clozapine in the clinic.