摘要: |
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 C18色谱柱(250 mm×4.6 mm,5 μm),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0.1~8.0 μg/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,r2=0.999 5。日内和日间精密度的RSD均不超过10%,定量限为0.066 μg/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。 |
关键词: 高效液相色谱 伏立康唑 血浆浓度 |
DOI:10.13407/j.cnki.jpp.1672-108X.2017.06.012 |
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基金项目:2015 年江苏省药学会-百特生物药学基金,编号201507。 |
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Determination of Voriconazole Concentrations in Plasma by HPLC |
Hao Ye, Wang Yongren |
(Children's Hospital of Nanjing Medical University, Jiangsu Nanjing 210008, China) |
Abstract: |
Objective: To establish a method to determine plasma voriconazole concentration by high performance liquid chromatography (HPLC). Methods: Kromasil 100-5 C18 column (250 mm×4.6 mm, 5 μm), mobile phase of acetonitrile-0.02 mol/L tetrabutyl ammonium bisulfate solution (50∶50 ), a flow rate of 1.0 mL/min, column temperature of 30 ℃ were selected. Results: The linear relation between peak area and concentration of the voriconazole in plasma were good at 0.1~8.0 μg/mL range. The regression equation was R=1.077,9C-0.040,7, r2=0.999,5. Intra-day and inter-day RSD were not more than 10%, the limit of quantitation was 0.066 μg/mL. Conclusion: This method is fully meeting the needs and requirements of the relevant guidelines for clinical trials, it can provide reference for determination of voriconazole concentration in plasma and pharmacokinetic studies. |
Key words: HPLC voriconazole concentrations in plasma |