UV-标准曲线法测定赖氨酸磷酸氢钙片中赖氨酸含量不确定度评定

目的: 建立UV-标准曲线法测定赖氨酸磷酸氢钙片中赖氨酸含量不确定度分析方法。 方法: 通过UV-标准曲线法的数学公式模型,采用直接代入计算法进行评估。 结果: 计算各变量的不确定度,由此计算合成不确定度,最终给出测定结果的相对扩展不确定度为3.9%。 结论: 测量不确定度可用于对赖氨酸磷酸氢钙片中赖氨酸含量测定结果的评价,测量不确定度的评定对于使用和改进药品标准具有重要意义。

Objective: To establish an uncertainty analysis method for determination of lysine hydrochloride in lysine hydrochloride and calcium hydrogen phosphate tablets with UV curve standardization. Methods: A mathematic model was established with UV curve standardization to identify the influence factors impacting uncertainty and each component of uncertainty was also evaluated by direct substitution algebra. Results: Each component of uncertainty was calculated by analyzing the various variable parameters in the procedure,the combined uncertainty and expanded uncertainty were finally obtained. Conclusion: The mathematic model of uncertainty was established in this paper is applicable to evaluate the accuracy of determination of lysine hydrochloride in lysine hydrochloride and calcium hydrogen phosphate tablets.The establishment of the methodology for the evaluation of measurement uncertainty is important for the use and improvement of drug standard.