限进介质-HPLC法与荧光偏振免疫法测定人血浆中卡马西平浓度的比较

RAM - HPLC vs. FPIA for Determination of Plasma Concentration of Carbamazepine

目的：建立以限进介质-高效液相色谱（RAM—HPLC）法测定患者血浆中卡马西平（CBZ）浓度的方法，并与荧光偏振免疫（FPIA）法测定结果进行比较。方法：血浆样品离心后，静脉血浆用FPIA法和RAM—HPLC法测定，指端血浆仅用RAM—HPLC法测定。其中，色谱柱为Hisep shielded hydrophobic phase分析柱，流动相为醋酸铵缓冲液-乙腈（88：12），流速为1．5mL·min^-1，检测波长为280nm，进样量为20μL，柱温为室温。结果：FPIA法测定静脉血浆CBZ的结果与RAM—HPLC法分别测定静脉和指端血浆CBZ的结果有良好的相关性（r分别为0．989、0．995），但有显著性差异（P〈0．05）；RAM—HPLC法测定静脉和指端血浆CBZ的结果亦有良好相关性（r=0．998），但无显著性差异（P〉0．05）。结论：RAM—HPLC法和FPIA法均可测定CBZ浓度，FPIA法更适合常规监测，RAM—HPLC法更适合相关研究和特殊病例监测。2种测定方法均不需样品前处理，有良好的重现性。

OBJECTIVE： To develop a RAM（Restricted -access media） - HPLC for the determination of plasma concentration of carbamazepine, and to compare the determination results with those determined by FPIA method. METHODS： The plasma samples were centrifugalized, then the venous plasma samples were determined by. FPIA and RAM- HPLC, respectively, while the fingertip plasma sample was determined by RAM - HPLC alone. The chromatographic column was Hisep shielded hydrophobic phase analytical column, and the mobile phase consisted of ammonium acetate buffer - acetonitrile （88 ： 12） at a flow rate of 1.5 mL ·in ^-1. The detective wavelength was set at 280 nm; the sample size was 20μL and the column temperature was kept at room temperature. RESULTS： A good correlation was noted between the carbamazepine concentration in venous plasma sample determined by FPIA and carbamazepine concentrations in either venous or fingertip plasma determined by RAM - HPLC, with the correlation coefficients being 0. 989 and 0.995, respectively, but the differences were significant（P〈 0.05）. Carbamazepine concentrations in venous and fingertip plasma samples determined by RAM -HPLC were consistent with each other（ r = 0. 998） but the differences were nonsignifieant（P 〉0.05）. CONCLUSION： Both RAM - HPLC and FPIA are applicable for the determination of carbamazepine concentration, but FPIA is more suitable for routine moni- toring while RAM - HPLC is more suitable for the related research and monitoring of specific cases. Both methods shows good reproducibility and in which the samples don＇t have to be pretreated.