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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 UV-calibration curve method for the determination of lysine in lysine calcium phosphate tablets. Methods: Mathematical formula model of UV-standard curve method was used to evaluate by direct substitution calculation method. Results: The uncertainty of each variable was calculated, and the composite uncertainty was calculated. Finally, the relative expanded uncertainty of the measurement results was 3.9%. Conclusion: Uncertainty in measurement can be used to evaluate lysine content in lysine-dicalcium phosphate tablets. Evaluation of measurement uncertainty is of great significance for the use and improvement of drug standards.