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目的:建立HPLC法测定注射用阿洛西林钠含量的不确定度分析方法。方法:通过建立HPLC含量测定法的数学模型,找出影响不确定度的因素并对各个不确定度分量进行评估。结果:计算出合成不确定度,并求出测定结果的扩展不确定度和置信区间。结论:测量不确定度可用于对注射用阿洛西林钠含量测定结果的评估。
Objective: To establish an HPLC method for the determination of sodium azlocillin injection uncertainty analysis. Methods: By establishing a mathematical model of HPLC determination method, find out the factors that affect the uncertainty and evaluate each component of uncertainty. Results: The composite uncertainty was calculated and the expanded uncertainty and confidence interval of the determination results were obtained. Conclusion: Uncertainty of measurement can be used to assess the results of the determination of the content of azlocillin sodium for injection.