不同方法对氨基比林纯度联合定值及不确定度评定

Valuation and Uncertainty Evaluation of the Purity Determination of Aminopyrine by Different Methods

目的:采用两种不同原理方法对氨基比林纯度联合定值,并建立其不确定度评定方法。方法:采用高效液相色谱法(HPLC)与酸碱滴定法对氨基比林纯度进行测定,并依据标准物质技术规范及相关计量技术规范要求,对两种不同原理方法测定过程的不确定度进行系统分析。结果:采用HPLC与酸碱滴定法联合测定氨基比林纯度的标准值及其不确定度为99.66%±0.08%(k=2,P=0.95)。结论:采用HPLC与酸碱滴定法联合测定氨基比林纯度及不确定度评定结果准确可靠,避免了采用一种技术带来的分析方法缺陷,有利于提高氨基比林的质量评价与控制水平,同时对氨基比林纯度标准物质的研制提供科学依据。

Objective： To study the valuation and uncertainty evaluation of the purity determination of aminopyrine by two different principle methods. Methods： According to Technical Norm of Primary Reference Material and Technical Norm of Measurement, HPLC and acid-base titration were selected for studying the valuation of the purity determination of aminopyrine, and the uncertainty evaluation of the two different principle methods was systematically evaluated. Results： By using the two different principle methods, the standard value and uncertainty of aminopyrine content was 99.66% ~ 0.08% （k = 2 ,P = 0.95 ）. Conclusion： The valuation and uncertainty evaluation of the purity determination of aminopyrine by using HPLC and acid-base titration are accurate and reliable, which can avoid the defects by using single analysis method, and is helpful to improve the level of quality evaluation and control of aminopyrine. The study provides scientific basis for the development of aminopyrine purity reference materials.