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高效液相色谱法测定复方氟尿嘧啶口服溶液中氟尿嘧啶含量的不确定度分析

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目的 评估高效液相色谱法(HPLC)测定复方氟尿嘧啶口服溶液中氟尿嘧啶含量的不确定度.方法 参考JJF 1135-2005《化学分析测量不确定度评定》和JJF 1059.1-2012《测量不确定度评定与表示》中的有关规定,建立氟尿嘧啶不确定评价数学模型,并对不确定度的来源进行分析,计算合成不确定度并确定测量结果在95%置信区间下的扩展不确定度.结果 采用本方法测定复方氟尿嘧啶口服溶液中氟尿嘧啶的扩展不确定度为1.6%,k=2.结论 本研究建立了高效液相色谱法测定复方氟尿嘧啶口服溶液中氟尿嘧啶含量的不确定度评定方法,明确其不确定来源主要是对照品的称量及供试品的稀释,为提高检验的准确性和科学性提供了理论指导.
Uncertainty evaluation for content determination of fluorouracil in compound fluorouracil oral solution by HPLC
Objective To evaluate the uncertainty for content determination of fluorouracil in compound fluorouracil oral solution by HPLC.Methods With reference to JJF 1135-2005 Evaluation of measurement uncertainty in chemical analy-sis and JJF 1059.1-2012 Evaluation and expression of measurement uncertainty,the mathematical models to evaluate and analyze the source of uncertainty in the content determination of fluorouracil were established.The synthetic uncertainty was calculated and the extended uncertainty of the measurement results under 95%confidence interval was determined.Results The extended uncertainty for the content determination of fluorouracil in compound fluorouracil oral solution by this meth-od was 1.6%,k=2.Conclusion In this study,an uncertainty evaluation method for the content determination of fluorou-racil in compound fluorouracil oral solution by HPLC is established.It is clear that the source of uncertainty is mainly the weighing of reference substance and the dilution of test substance,which provide theoretical guidance for improving the ac-curacy and scientificity of the test.

Compound fluorouracil oral solutionFluorouracilHigh performance liquid chromatographyUncertainty

王丹、马晓静、高楠楠、崔业波、马彧

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四平市食品药品检验所中药室,吉林 四平 136000

复方氟尿嘧啶口服溶液 氟尿嘧啶 高效液相色谱法 不确定度

2024

中国卫生工程学
中华预防医学会,吉林省预防医学会

中国卫生工程学

影响因子:0.416
ISSN:1671-4199
年,卷(期):2024.23(5)