摘要
目的建立替硝唑胶囊含量测定中不确定度的分析方法。方法采用HPLC法测定含量的数学模型,确定影响不确定度的因素并对各个不确定度因素进行评估。结果替硝唑胶囊含量测定的合成不确定度为0.9%;扩展不确定度为1.8%;测定结果为(99.1±1.8)%。结论本方法可用于HPLC法测定该制剂含量的不确定度分析。
Aim To establish a method for uncertainty analysis in HPLC determination.Method The calculation formula of uncertainty was deduced in the procedure of determining the content in capsules.Results The combined uncertainty was 0.9 %,the extended uncertainty was 1.8%,and the determined content were 99.1%±1.8%.Conclusion The mathematic model of uncertainty measurement established in this paper is reasonable and reliable.
出处
《安徽医药》
CAS
2010年第7期776-777,共2页
Anhui Medical and Pharmaceutical Journal
