评定固相萃取-HPLC法测定人血清中10-羟基卡马西平浓度的不确定度

发布时间：2018-08-19 15:57

【摘要】：目的评定固相萃取-高效液相色谱法测定人血清中奥卡西平活性代谢物10-羟基卡马西平浓度的不确定度。方法对固相萃取-HPLC法测定人血清中10-羟基卡马西平浓度的实验,全过程进行分析,确定并简化不确定度来源,用方法学验证数据并根据相关评定程序,依次计算各变量的不确定度、合成不确定度和扩展不确定度。结果人血清中低、中、高3个浓度(3.18,12.73,50.91μg·m L-1)10-羟基卡马西平的扩展不确定度分别为0.24,0.44,1.66μg·m L-1(k=2,P=95%)。结论本方法的不确定度主要由标准曲线拟合(尤其是低浓度)、血清药物提取、血清样品制备、仪器允差及测定重复性引入。
[Abstract]:Objective to evaluate the uncertainty of solid phase extraction (SPE)-high performance liquid chromatography (HPLC) for the determination of 10-hydroxycarbamazepine in human serum. Methods solid phase extraction-HPLC method was used to determine the concentration of 10-hydroxycarbamazepine in human serum. The whole process was analyzed to determine and simplify the source of uncertainty. The uncertainty of each variable, the synthetic uncertainty and the extended uncertainty are calculated in turn. Results the extended uncertainty of 10-hydroxycarbamazepine at 3 concentrations (3.18 ~ 12.73 渭 g 路mL ~ (-1) was 0.24 ~ 0.44 ~ 1.66 渭 g / m ~ (-1) (K ~ (2 +) P ~ (-1) 95%). Conclusion the uncertainty of this method is mainly introduced by standard curve fitting (especially low concentration), serum drug extraction, serum sample preparation, instrument tolerance and repeatability.
【作者单位】：武汉市儿童医院药学部;
【基金】：2014年度武汉市临床医学科研基金资助项目(WX14C47)
【分类号】：R927.2;O657.72

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