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。
Objective: To evaluate the measurement uncertainty in the determination of sodium valproate tablets by GC with an in- ternal standard method, and determine the main sources of uncertainty. Methods: A GC internal standard method was selected to sys- tematically 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.
出处
《中国药师》
CAS
2016年第6期1217-1220,共4页
China Pharmacist
关键词
丙戊酸钠
含量
不确定度
气相色谱法
内标法
Sodium valproate tablets
Determination
Uncertainty
GC
Internal standard method