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目的建立HPLC法测定人血浆中氟康唑浓度的方法,用于临床患者使用氟康唑后血药浓度监测和药动学研究。方法以非那西丁为内标,采用Agilent ZORBAX SB-C_(18)色谱柱(150 mm×4.6 mm,5μm),流动相:水-乙腈(78:22),流速:1.0 ml·min~(-1),检测波长260 nm。结果当氟康唑血药浓度在0.5~15μg·ml~(-1)范围内线性关系良好(n=7,r=0.999);低、中、高3个浓度的绝对回收率分别为89.44%、94.02%、83.59%,方法回收率分别为105.46%、104.81%、110.52%;日内、日间精密度和短期、长期稳定性的RSD均小于10%,样本提取后及2次冻融稳定性良好。结论本法简便、灵敏、回收率高、重复性好,可用于患者的血药浓度监测和药动学研究。
Objective To establish a method for the determination of fluconazole in human plasma by HPLC and to study the plasma concentration monitoring and pharmacokinetics of fluconazole in clinical patients. Methods The phenazine was used as the internal standard. The mobile phase consisted of water - acetonitrile (78:22) and flow rate of 1.0 ml · min ~ (-1) at room temperature on a ZORBAX SB-C 18 column (150 mm × 4.6 mm, (-1), detection wavelength 260 nm. Results The linearity of fluconazole in the range of 0.5 ~ 15μg · ml ~ (-1) was good (n = 7, r = 0.999). The absolute recoveries of low, middle and high concentrations were 89.44% , 94.02% and 83.59% respectively. The RSDs of the method were 105.46%, 104.81% and 110.52% respectively. The RSDs of intra-day and inter-day precision and short-term and long-term stability were less than 10% good. Conclusion This method is simple, sensitive, high recovery, good repeatability, and can be used for the monitoring of plasma concentration and pharmacokinetics in patients.