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目的:建立检测血浆中伏立康唑浓度的高效液相色谱(HPLC)法。方法:采用Kromasil 100-5 C_(18)色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.02 mol/L四丁基硫酸氢铵溶液(50∶50),流速1.0 mL/min,柱温30℃。结果:伏立康唑在0.1~8.0μg/mL血药浓度范围内与峰面积线性关系良好,回归方程为R=1.077 9C-0.040 7,r~2=0.999 5。日内和日间精密度的RSD均不超过10%,定量限为0.066μg/mL。结论:该方法完全满足临床实验的需要和相关指导原则的要求,可为临床伏立康唑血浆浓度检测和药动学研究提供参考。
Objective: To establish a high performance liquid chromatography (HPLC) method for the determination of voriconazole in plasma. Methods: Kromasil 100-5 C 18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase was acetonitrile-0.02 mol / L tetrabutylammonium hydrogen sulfate solution (50:50) at a flow rate of 1.0 mL / min The column temperature was 30 ℃. Results: Voriconazole had a good linear relationship with the peak area in the concentration range of 0.1 ~ 8.0μg / mL. The regression equation was R = 1.077 9C-0.040 7, r 2 = 0.999 5. The RSDs for intra- and inter-day precision did not exceed 10% with a limit of quantification of 0.066 μg / mL. Conclusion: This method fully meets the needs of clinical trials and the requirements of the relevant guidelines. It can provide a reference for clinical voriconazole plasma concentrations and pharmacokinetic studies.