RP-HPLC法测定人血清氟康唑浓度及其临床应用

Determination of fluconazole concentration in human serum by RP-HPLC and its clinical application

目的：建立反相高效液相色谱法（RP-HPLC）以测定人血清中氟康唑浓度,并用于临床1例氟康唑引起肝损害患者的药物浓度测定。方法：色谱柱为XDB C18柱（150 mm×4.6 mm,5μm）,流动相：0.01mol.L-1磷酸二氢钾（pH7.4）-乙腈-甲醇（74∶16∶10）,流速：1.0 mL.min-1,检测波长：210 nm;内标：氯丙那林。结果：血清氟康唑浓度在0.2~20μg.mL-1内线性良好,回归方程Y=0.188 4X＋0.010 4（n=7,r=0.999 8）,日内精密度RSD〈5.36%,日间精密度RSD〈10.83%,方法提取回收率为74.15%~80.68%。结论：本测定方法快速、灵敏,适用于氟康唑的血清浓度测定。[关键词]氟康唑;反相高效液相色谱法;

Objective：To establish a method for determination of fluconazole in human serum by RP-HPLC.Methods：Separation was carried out on a XDB C18 column（150 mm×4.6 mm,5 μm）.The mobile phase consisted of phosphate buffer（0.01 mol·L-1,pH 7.4）,acetonitrile and methanol（74∶16∶10）;flow rate was 1.0 mL·min^-1;and UV detector wavelength was 210 nm.Clorprenaline was used as the internal standard.Results：The linear range of fluconazole was 0.2-20 μg·mL^-1 with a linear equation Y=0.188 1X-0.010 6（n=7,r=0.999 8）.The intra-day and inter-day precisions were less than 5.36% and 10.83%,respectively.The extraction recovery was 74.15%~80.68%.Conclusion：The validated method is rapid and sensitive.It can be successfully used in the determination of clinical samples.