摘要
目的:建立 HPLC 法测定非那雄胺片含量及含量均匀度的不确定度分析方法。方法:通过建立 HPLC 法测定含量及含量均匀度的数学模型,找出影响不确定度的因素并对各个不确定度分量进行评估。结果:计算各变量的不确定度,由此计算合成不确定度,最终给出测量结果的扩展不确定度和置信水平。结论:建立的不确定度评估方法可用于 HPLC 法测定各类制剂含量及含量均匀度的不确定度的分析。
Objective：To establish a method for uncertainty analysis in HPLC determination. Methods：The calculation formula of uncertainty was deduced in the procedure of determining the content and content uniformity in tablets. Results：Each component of uncertainty was calculated by analyzing the variable parameters among the procedures. The combined uncertainty was finally obtained by synthesizing the uncertainties of various component variables. Conclusion ： The mathematic model of uncertainty measurement established in this paper is reasonable and reliable.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2005年第10期1244-1247,共4页
Chinese Journal of Pharmaceutical Analysis
