高效液相色谱法测定人血浆中伏立康唑的含量

Determination of the concentration of voriconazole in human plasma by HPLC

目的建立高效液相色谱法测定人血浆中伏立康唑浓度的方法学。方法色谱柱:ZORBAX Eclipse Plus C_(18),柱温:40℃,流速:1 mL·min^(-1),流动相:甲醇-水=55∶45,检测波长:254 nm,内标:对氯苯乙酰胺。考察该方法的专属性、标准曲线与定量下限、精密度与回收率、稳定性。结果血浆中内源性杂质对样品测定无干扰,血浆中伏立康唑在0.1~10.0μg·mL^(-1)内线性良好(r=0.999 2),最低检测浓度为0.1μg·mL^(-1)。血浆中伏立康唑日内、日间RSD均<10%,提取回收率为89%~92%。结论本方法简便、灵敏、准确、高效,适用于人体内伏立康唑的浓度监测。

Objective To establish a HPLC method for determining the concentration of voriconazole（ VRC） in human plasma. Methods The analysis was conducted using a ZORBAX Eclipse Plus C_（18） column and the column temperature was 40 ℃. The mobile phase consisted of methanol and water（ 55∶ 45）. The flow rate was 1 mL·min^（-1） and the detection was performed at 254 nm. And the internal standard substance was p-Chloroacetanilide. The specificity,lower limit of quantitation（ LLOQ）,standard curve,precision,accuracy,recovery and stability were investigated. Results Endogenous impurities did not interfere with the determination of the samples in plasma. The standard curve was linear in the range of 0. 1-10. 0 μg·mL^（-1）（ r = 0. 999 2）,LLOQ was 0. 1μg·mL^（-1）. The RSDs of inter-day and intra-day were all less than10% in the plasma and the extraction recovery was 89%-92%.Conclusion This method was simple,sensitive,accurate,efficient and suitable for routine determination of the concentration of VRC in human plasma.