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气相色谱法检测多西环素中乙醇含量的不确定度评定
季璇,王轩,戴青,赵晖,韩宁宁,杨秀玉
0
(中国兽医药品监察所)
摘要:
为提高检验结果的准确性,确定检验过程中的关键影响因素,对气相色谱内标法测定多西环素中乙醇的含量进行不确定度评估。依据《中国兽药典》2020版多西环素质量标准对其乙醇含量进行测定,分析影响不确定度的因素,参照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》中的规定及要求,对检验过程中的不确定因素进行评估,根据CNAS-GL006:2019构建了乙醇含量的不确定度评估数学模型,,对检测过程中各种不确定度的来源进行分析,并计算合成相对标准不确定度和扩展不确定度。多西环素中乙醇含量的不确定度结果表示为(5±0.06)%,(k=2,置信区间为95%)。多西环素中乙醇含量的不确定度主要来源于供试品溶液的配制。
关键词:  气相色谱内标法  多西环素  乙醇  不确定度
DOI:
投稿时间:2022-05-24修订日期:2022-11-07
基金项目:
Uncertainty Evaluation on Determination of Ethanol Content in Doxycycline by Gas Chromatography
(China Institute of Veterinary Drug Control)
Abstract:
Abstract: Evaluating the uncertainty on determination of ethanol content in doxycycline by gas chromatography can be used to improve the accuracy of the test results and determine the key influencing factors in the test process. The ethanol content in doxycycline was tested according to Chinese Veterinary Pharmacopoeia 2020 edition, and the factors affecting the uncertainty were analyzed. Referring to Evaluation of Measurement Uncertainty in Chemical Analysis JJF 1135-2005, Evaluation and Representation of Measurement Uncertainty JJF 1059.1-2012 and Guidance on Evaluating the Uncertainty in Chemical Analysis (CNAS-GL006:2019), a mathematical model for the uncertainty evaluation of ethanol content was built to evaluate the uncertain factors in the test. The sources of uncertainty were analyzed, and the combined relative standard uncertainty and expanded uncertainty were calculated. Uncertainty results of ethanol content in doxycycline were expressed as (5±0.06)%, (k=2, The confidence interval is 95%). The uncertainty of ethanol content in doxycycline mainly comes from the preparation of the test solution.
Key words:  gas chromatography  doxycycline  ethanol content  uncertainty

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