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· min ~(-1). The detective wavelength was set at 280 nm; the sample size was 20 μL 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(P0.05). CONCLUSION: Both RAM-HPLC and FPIA are applicable for the determination of carbamazepine concentration, but FPIA is more suitable for routine monitoring 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.%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280 nm,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(P0.05).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.
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