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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。
Objective: To establish a GC internal standard method for the determination of sodium valproate tablets uncertainty, and to determine the main sources of measurement uncertainty. Methods: The systematic analysis was made on the uncertainty of multiple components such as the sample quantity, the dilution factor, the purity and the area repeatability of chromatographic peak area introduced by GC internal standard method in the determination of sodium valproate tablets. Results: The expanded uncertainty of GC content was 2.7% and the content of sodium valproate was (96.3 ± 2.7)% (k = 2). Conclusion: The established uncertainty assessment results are reliable and the results are helpful to improve the quality evaluation and control of sodium valproate tablets.