氯氮平血药浓度快速测定方法的研究

Rapid Determination of Clozapine in Blood by RP-HPLC

建立了一种反相高效液相色谱法测定人血清中氯氮平浓度。采用 μBondapakC18(30 0mm× 3 9mm ,10 μm)柱 ,甲醇—水—三乙胺 (78∶2 2∶0 5 ,冰醋酸调pH 8 0 )为流动相 ,检测波长6 0 0nm (0→ 2 5min) ,2 30nm (2 5→ 6 0min) ,流速 1 4mL/min ,柱温 4 5℃ ,灵敏度 0 0 0 1AUFS ,选用安定为内标 ,血清样品经 75 %三氯醋酸沉淀蛋白后直接进样测定。线性范围 5 0 4～ 1176ng/mL ,r=0 9996 (n =7) ,平均回收率 10 0 9%～ 10 2 9% (RSD<5 0 % ,n =3)。日内RSD <2 5 6% ,日间RSD <3 2 5 % ,n=16 。

In this article,a RP-HPLC method was established for rapid determination of clozapine(CZP)concentration in human serum.The chromatographic condition was adopted as follows:μ Bondapak C 18 column(300 mm×3 9 mm,10 μm),the mobile phase consisted of methanol-water-triethylamine(78∶22∶0 5,adjusted pH to 8 0 with glacial acetic acid),wavelength of detection 600 nm(0→2 5 min),230 nm(2 5→6 0 min),flow rate 1 4 mL/min,column temperature 45 ℃,sensitivity 0 001AUFS,diazepam was used as internal standard.The serum sample was injected directly for determination after being deproteinized with 75 % trichloroacetic acid.A good linear relationship existed in the range of CZP from 50 4 to 1176 ng/mL,r=0 9996(n=7).The average recovery was 100 9 %～102 9 %(RSD<5 0 %,n=3),within-day RSD<2 56 %(n=16),between-day RSD<3 25 %(n=16).The lowest concentration for detection was 33 6 ng/mL.This method can be used as a routine method in TDM.