高效液相色谱法测定兽药伊维菌素注射液含量的不确定度评定

Uncertainty Evaluation for Determination of the Content of Ivermectin in Ivermectin Injection by HPLC

关键词:  高效液相色谱法  伊维菌素注射液  不确定度

Key words:  HPLC  Ivermectin Injection  Uncertainty

摘要:

通过建立数学模型，对高效液相色谱法测定兽药伊维菌素注射液中伊维菌素的含量进行不确定度评定，分析不确定度来源及其对测定过程中不确定度的相对贡献，并计算合成不确定度，最终得到兽药伊维菌素注射液中伊维菌素含量的扩展不确定度。当伊维菌素注射液含量为101.5%时，在95%的置信区间下，扩展不确定度为3.0%（k=2）。 实验过程中的不确定度主要来源于标准工作曲线系列溶液的配制、样品前处理及对照品贮备液配制环节，测量过程中应重点关注并严格加以控制。研究可为兽药检测机构测定兽药伊维菌素注射液含量的质量控制提供参考。

Abstract:

To evaluate the uncertainty for determination of the content of Ivermectin Injection by HPLC through establishing a mathematical model, the uncertainty of determination of the content of Ivermectin Injection was evaluated. The source of uncertainty and its relative contribution to the uncertainty in the determination process were analyzed, and the synthetic uncertainty was calculated as well. Finally, the extension uncertainty of Ivermectin in Ivermectin Injection was obtained. Under the 95% confidence interval, while the Ivermectin content was 101.5%，the extension uncertainty was 3.0% (k=2) . The evaluation shows that the uncertainties of the experiment are mainly derived from preparations of serial standard working solutions, samples, and the standard storage solution, which should be paid more attention to and be controlled carefully when measuring. The article could provide suggestion for veterinary drug testing institutes to control its quality when measure the content of Ivermectin in Ivermectin Injection.