气相色谱内标法测定丙戊酸钠片含量的不确定度评定

摘 要 目的：建立GC内标法测定丙戊酸钠片含量不确定度评定方法，确定引入测量不确定度的主要来源。方法: 对采用GC内标法测定丙戊酸钠片含量过程中引入的称样量、稀释倍数、纯度、色谱峰面积重复性等多个分量不确定度进行系统分析。结果: GC内标法测定丙戊酸钠片含量扩展不确定度为2.7%，含量范围为（96.3±2.7）% （k=2）。结论:建立的不确定度评定结果可靠，其结果有利于提高丙戊酸钠片的质量评价与控制水平。

Uncertainty Evaluation in the Determination of Sodium Valproate Tablets by GC with an Internal Standard Method

ABSTRACT Objective: To evaluate the measurement uncertainty in the determination of sodium valproate tablets by GC with an internal standard method, and determine the main sources of uncertainty.Methods:A GC internal standard method was selected to systematically analyze the uncertainty in the determination of sodium valproate tablets, including the sample quantity, dilution ratio, purity and area repeatability of chromatographic peaks. Results:The expanded uncertainty of sodium valproate tablets was 2.7%, and the determination range of sodium valproate tablets was (96.3±2.7)% (k=2).Conclusion:The established GC internal standard method for the uncertainty evaluation is reliable, which is helpful to improving the quality evaluation and control of sodium valproate tablets.