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目的对高效液相色谱(HPLC)法测定人血清中拉莫三嗪浓度的不确定度进行评定。方法用HPLC法测定人血清中拉莫三嗪浓度,分析称量、溶液配制、血清提取、标准曲线拟合及测量重复性等因素对结果的影响,计算各因素的不确定度及合成不确定度,并评定扩展不确定度。结果 HPLC法测定人血清中拉莫三嗪低(1.50μg·mL~(-1))、中(8.00μg·mL~(-1))、高(20.00μg·mL~(-1))3个质量浓度质控样品的扩展不确定度分别为UL=0.30,UM=0.53,UH=0.98(P=95%,k=2);其相应检测浓度结果表示为(1.51±0.30),(8.22±0.53),(20.40±0.98)μg·mL~(-1)。结论本方法的相对测定不确定度主要是由重复性、线性拟合及提取回收过程引入,影响低浓度测定结果的因素主要是线性拟合及测量重复性。
Objective To evaluate the uncertainty of determination of lamotrigine in human serum by high performance liquid chromatography (HPLC). Methods The concentration of lamotrigine in human serum was determined by HPLC. The effects of weighing, solution preparation, serum extraction, standard curve fitting and measurement repeatability on the results were analyzed. The uncertainty of each factor and the uncertainty of synthesis were calculated Degree, and assess the expansion of uncertainty. Results The results of HPLC showed that lamotrigine low (1.50μg · mL -1), medium (8.00μg · mL -1), high (20.00μg · mL -1) 3 The uncertainty of the quality control samples were UL = 0.30, UM = 0.53, UH = 0.98 (P = 95%, k = 2) .The corresponding detection results were (1.51 ± 0.30) ± 0.53), (20.40 ± 0.98) μg · mL -1. Conclusion The relative uncertainty of this method is mainly caused by the repetitiveness, linear fitting and extraction and recovery process. The main factors affecting the determination of low concentration are linear fitting and repeatability.