| 摘要: |
| 为分析评定氟苯尼考可溶性粉含量测定的不确定度，通过高效液相色谱（HPLC）法进行测定，建立HPLC法测定氟苯尼考可溶性粉含量的数学模型。以Agilent ZORBAX SB-C18（250mm×4.6mm，5μm）为色谱柱，乙腈-水-冰醋酸（100:197:3）为流动相，柱温：30℃，检测波长：224nm。分析各因素引入的标准不确定度分量，合成标准不确定度，评定测定结果在95%置信区间的扩展不确定度，给出不确定度评定结果报告。测定结果表明，含量测定的不确定度主要源于称量、溶液配制及峰面积测定过程。含量测定的标准不确定度为 1.16%，扩展不确定度为2.32%。含量测定结果表示为（97.3±2.32）%，包含因子k＝2。该方法适用于HPLC法测定氟苯尼考可溶性粉含量的不确定度评定，可为氟苯尼考可溶性粉的质量控制和客观评价提供参考。 |
| 关键词: 不确定度 氟苯尼考可溶性粉 高效液相色谱法 |
| DOI： |
| 投稿时间：2023-03-15修订日期：2023-12-19 |
| 基金项目: |
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| Evaluate the Uncertainty of the Content Determination of Florfenicol Soluble Powder |
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| (Liaoning GuoTuo Testing Co.,LTD) |
| Abstract: |
| In order to analyze and evaluate the uncertainty in the determination of florfenicol soluble powder, high performance liquid chromatography (HPLC) was used to determine the content of florfenicol soluble powder, and established the mathematical model for the determination. Agilent Zorbax SB-C18 (250 mm× 4.6 mm, 5 μm) was used as the chromatographic column, Acetonitrile - Water - Glacial Acetic acid (100:197:3) as the mobile phase, the column temperature was 30℃, and the detection wavelength was 224nm. Analyze the standard uncertainty components introduced by various factors, synthesize the standard uncertainty, evaluate the expanded uncertainty of the measurement results in the 95% confidence interval, and give the uncertainty evaluation result report. The results show that the uncertainty of content determination mainly comes from weighing, solution preparation and peak area determination. The standard uncertainty of content determination is 1.16% and the extended uncertainty is 2.32%. The content determination result is (97.3±2.32)%, including factor k = 2. This method is suitable for the uncertainty evaluation of the content determination of florfenicol soluble powder by HPLC, and can provide reference for the quality control and objective evaluation of florfenicol soluble powder. |
| Key words: uncertainty florfenicol soluble powder high performance liquid chromatography |
