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| 液相色谱法测定氟尼辛葡甲胺注射液含量的不确定度评定 |
| 金晓峰,孙真峥,赵贵,王庆红,章厉劼,栾庆祥,黄鑫,周泽晓,谢丽丽,王璇,陈灵,古海,文正常 |
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| (贵州省兽药饲料检测所) |
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| 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，对液相色谱法测定氟尼辛葡甲胺注射液含量进行不确定度评估。依据《中国兽药典》2020 版氟尼辛葡甲胺注射液质量标准对其含量进行测定，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 构建了氟尼辛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?氟尼辛葡甲胺注射液含量的不确定度结果表示为(102.2 ± 2.72)% ,（k = 2,置信区间为 95% ），主要来源于仪器重复性? |
| 关键词: 液相色谱法 氟尼辛葡甲胺注射液 氟尼辛 不确定度 |
| DOI： |
| 投稿时间：2023-07-06修订日期：2023-12-25 |
| 基金项目:贵州省科技计划项目（黔科合成果[2021]一般039） |
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| Uncertainty Evaluation on Determination of Content of Flunixin Meglumine Injection by liquid Chromatography |
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| (Guizhou Veterinary Medicine and Feed Testing Institute) |
| Abstract: |
| Evaluating the uncertainty on determination of flunixin content in flunixin meglumine injection by liquid chromatography can be used to improve the accuracy of the test results and determine the key influencing factors in the test process. The flunixin content in flunixin meglumine injection 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 flunixin 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 flunixin content in flunixin meglumine injection were expressed as (102.2±2.72)%, (k =2, The confidence interval is 95%). The uncertainty of flunixin content in flunixin meglumine injection mainly comes from the preparation of the Instrument repeatability. |
| Key words: liquid chromatography flunixin flunixin meglumine injection uncertainty |
