摘要
目的比较酶放大免疫分析法(EMIT)与二维液相色谱法(2D-HPLC)测定卡马西平血药浓度的差异。方法采集67例癫痫患者卡马西平血清样本,分别采用EMIT法和2D-HPLC法测定,其中二维液相的色谱条件如下:第一维色谱柱为ASTON-FAQ C8柱(4.0 mm×100.0 mm,3μm,ANAX),流动相为乙腈-水(55∶45,v/v),流速为1 m L/min;中间柱为ASTON C18(4.6 mm×10.0 mm,3μm,ANAX);第二维色谱柱为Diamonsil-C18柱(4.6 mm×200.0 mm,5μm,Dikma),流动相为乙腈-20 mmol/L乙酸铵(20∶80,v/v,p H=7.0),流速为1.2 m L/min。柱温为40℃,检测波长为285 nm。结果两种方法差异无统计学意义,且相关性好,回归方程为y(2D-HPLC)=0.9876×x(EMIT)-0.0313,Bland-Altman分析显示两种方法一致性良好。结论 EMIT法与2D-HPLC法测定的结果具有良好的一致性和相关性,应综合考虑实验室条件和人员配置等方面,采用合适的测定方法。
Objective To compare the results of Carbamazepine in serum of patients with epilepsy determined by enzyme-multiplied immunoassay technique(EMIT)and two-dimensional liquid phase chromatography(2D-HPLC).Methods The serum concentration of Carbamazepine in 67 epilepsy patients was determined by EMIT and 2D-HPLC,respectively.In 2D-HPLC method,two reversed phase liquid chromatography columns[ASTON-FAQ C8(4.0 mm×100.0 mm,3μm,ANAX)and Diamonsil-C18(4.6 mm×200.0 mm,5μm,Dikma)column]were used as the first and second separation dimensions,respectively.ASTON C18(4.6 mm×10.0 mm,3μm,ANAX)column was used as a connector to transfer the eluent from the first dimensional column to the second column for further separation.The mobile phases of the two dimensions consisted of acetonitrile-H2O(55∶45,v/v)and acetonitrile-20 mmol/L ammonium acetate(20∶80,v/v,pH=7.0),respectively.The first dimensional column flow rate was 1.0 mL/min,the second dimensional column flow rate was 1.2 mL/min.The detection wavelength was 285 nm,and the column temperature was 40℃.Results There were no significant differences in the serum concentrations of Carbamazepine detected by EMIT and 2D-HPLC.A good correlation was obtained between the two methods.The regression equation was y(2D-HPLC)=0.9876×x(EMIT)-0.0313.Bland-Altman plots analysis showed the two methods were consistent.Conclusion Both EMIT and 2D-HPLC methods have good consistency and correlation in the quantification of Carbamazepine.The laboratory conditions and staffing should be taken into consideration when a method is chosen for monitoring the concentration of Carbamazepine.
作者
柳航
王敏
金路
张晋萍
LIU Hang;WANG Min;JIN Lu;ZHANG Jinping(Department of Pharmacy,the Affiliated Drum Tower Hospital of Nanjing University Medical School,Jiangsu Province,Nanjing 210008,China)
出处
《中国医药导报》
CAS
2018年第21期106-109,共4页
China Medical Herald
基金
国家自然科学基金青年基金项目(21602102)
江苏省卫生和计划生育委员会青年科研课题(Q201507)
关键词
卡马西平
血药浓度
酶放大免疫分析法
二维液相色谱法
Carbamazepine
Serum drug concentration
Enzyme-multiplied immunoassay technique
Two-dimensional liquid phase chromatography
