反相高效液相色谱法测定人血浆中卡马西平浓度及其临床应用

Determination of Carbamazepine Concentration in Human Plasma by Reversed-phase High Performance Liquid Chromatography (HPLC) and its Clinical Application

目的采用反相高效液相色谱法分析人血浆中卡马西平(CBZ)浓度。方法以Agilent ZORBAX Eclipse Plus-C18反相柱(150 mm×4.6 mm,5μm)为色谱柱,流动相为去离子水-乙腈-甲醇(30:10:60);流速:1.0 ml/min;检测柱温:35℃;检测波长:286 nm;灵敏度0.01 AUFS。选择乙酸乙酯作为提取剂。结果 CBZ浓度为2.0、8.0、36.0μg/ml时平均相对回收率分别为100.8%、99.81%、99.75%,提取回收率分别为78.33%、82.75%、86.26%;日内和日间相对标准偏差(RSD)值均低于10%(n=5);方法学的检测限0.5μg/ml;线性范围为1.0~48.0μg/ml。线性方程:C=40.538F-0.018,相关系数r=0.9998(n=7)。结论本方法具有操作简单、方法可靠、检测快速、结果准确等特点,可用于临床CBZ治疗药物监测(TDM)或药动学研究。

Objective To analyse the Carbamazepine(CBZ)concentration in human plasma by reversed-phase high performance liquid chromatography(HPLC).Methods Agilent ZORBAX Eclipse Plus-C18 reverse phase column(150 mm×4.6 mm,5μm)was used as the column,and the mobile phase was deionized water-acetonitrile-methanol(30:10:60);flow rate:1.0 ml·min-1;detection column temperature:35°C;detection wavelength:286 nm;sensitivity 0.01 AUFS.Ethyl acetate was chosen as the extractant.Results The rate of average relative recoveries of CBZ concentration at 2.0,8.0 and 36.0μg·mL-1)were 100.8%,99.81%,and 99.75%,respectively,and the rate of extraction recovery were 78.33%,82.75%and 86.26%,respectively;the intraday and interday relative standard deviation(RSD)values were all below 10%(n=5);the methodological detection limit was 0.5μg·mL-1;the linear range was1.0-48.0μg·mL-1.Linear equation:C=40.538 F-0.018,correlation coefficient r=0.9998(n=7).Conclusion The method has the characteristics of simple operation,reliable method,rapid detection and accurate results.Which can be used for clinical CBZ drug monitoring(TDM)or pharmacokinetic research.