王佳庆 赵志刚 梅升辉首都医科大学附属北京天坛医：药学部，北京100050

    HPLC法测定人血浆中万古霉素浓度的不确定度评定

    王佳庆赵志刚梅升辉

    首都医科大学附属北京天坛医：药学部，北京100050

    目的评定液相色谱(HPLC)法测定人血浆中万古霉素(VCM)浓度的不确定度。方法采用Ag1ient ZORBAX SB-C18色谱柱(4.6 mm×250 mm，5 μm)，流动相为30 mmo1/L磷酸二氢钾缓冲溶液-乙腈(91.5:8.5 pH值3.38)，流速1.1 mL/min，检测波长236 nm，柱温35℃。分析并评定HPLC法测定人血浆中VCM浓度过程中的不确定度来源并进行合成。结果人血浆中VCM低浓度(2.48 μg/mL)和高浓度(172.2 μg/mL)的扩展不确定度分别为0.168 μg/mL和9.64 μg/mL(P=95%，k=2)。结论用HPLC法测定人体血浆中万古霉素浓度的不确定度在高浓度时主要由基质效应、生物样品的配制及重复性引入，在低浓度时主要由回收率、基质效应及生物样品配制引入。

    高效液相色谱法；万古霉素；血清；不确定度

    [Abstract]Objective To eva1uate the uncertainty on the determination of vancomycin(VCM)in human p1asma by HPLC method.Methods The chromatography was performed on an Ag1ient ZORBAX SB-C18(4.6 mm×250 mm,5 μm)co1umn with the mobi1e phase consisting of 30 mmo1/L potassiumdihydrogen phosphate-acetonitri1e(91.5:8.5,pH 3.38)at the f1ow rate of 1.1 mL/min.UV detection was set at 236 nm and the co1umn temperature was set at 35℃.The uncertainty sources in the determinationof VCM were ana1yzed and the uncertainty was eva1uated and combined.Results The expanded uncertainty of VCM at 1ow(2.48 μg/mL)and high(172.2 μg/mL)concentrations were 0.168 μg/mL and 9.64 μg/mL respective1y(P=95%,k=2).Conclusion The uncertainty on the determination of VCM in human p1asma by HPLC method is main1y caused by recovery,matrix effectand samp1e preparation for 1ow concentrations,and the matrix effect, samp1e preparation and repeatabi1ity for high concentrations. ......