HPLC法测定人血清伏立康唑浓度  

The determination of voriconazole concentration in human serum by HPLC

作　　者：李辉[1] 赵宇蕾[1] 周国华[1] 芮建中[1] 

机构地区：[1]南京军区南京总医院药理科,南京210002

出　　处：《东南国防医药》2017年第1期30-33,共4页Military Medical Journal of Southeast China

摘　　要：目的建立高效液相色谱(high performance liquid chromatography,HPLC)测定人血清中伏立康唑的方法,为临床伏立康唑的个体化用药提供方法学基础。方法采用7%高氯酸直接沉淀血清蛋白,色谱柱采用汉邦Hedera ODS-2(4.6μm×250 mm,5μm),流动相为乙腈-20 mmol/L磷酸二氢钠缓冲液(pH=6.0)(60∶40,v/v),流速为1.0 mL/min,检测波长为254 nm。结果伏立康唑在0.367~23.5μg/mL间线性良好(r=0.9964),批内、批间准确度偏差<±5.0%,批内、批间精密度相对标准偏差(relative standard deviation,RSD)<11.1%,在室温放置、冰冻、反复冻融条件下考察样品稳定性,伏立康唑均保持稳定,偏差<±12.5%。结论建立的HPLC测定人血清伏立康唑浓度的方法具有操作简便、特异性高、灵敏度高、成本低的特点,更适合临床中常规应用。Objective To establish an high performance liquid chromatography（ HPLC） method to determine the voriconazole concentration in human serum,that will provide methodological foundation for individual medicine. Methods After the precipitation of serum proteins with 7% perchloric acid,the voriconazole concentration was determined by HPLC on a reversed phase Hedera ODS-2 column（ 4. 6 μm × 250 mm,5 μm）. The mobile phase was a mixture of acetonitrile and 20 mmol/L sodium dihydrogen phosphate buffer adjusted to pH 6. 0,with the mix ratio 60∶ 40,and was delivered at a flow rate of 1. 0 mL/min. The UV detection was set at 254 nm. Results The peak area for voriconazole was linearly related to its concentrations,which ranged from 0. 367 to 23. 5μg/mL（ r = 0. 9964）. The intra-and inter-assay variations were within ± 5. 0% and their relative standard deviation values were within 11. 1%. The serum samples were stable when stored at room temperature,after frozen for 15 days and after 3 cycles of freeze and thaw processes; deviations were within ± 12. 5%. Conclusion The established HPLC method is simple and fast with high specificity,high sensitivity and low cost. The improved method is more suitable for clinical routine use.

关 键 词：伏立康唑 高效液相色谱 血清浓度 

分 类 号：R969.3[医药卫生—药理学]