摘要
目的对苯磺酸氨氯地平片采用RP-HPLC测定方法的不确定度进行评估。方法采用因果图分析方法和相关数据模型量化分析方法中各不确定度分量,计算合成标准不确定度和扩展不确定度。结果各不确定度分量中由对照品质量分数引入的分量最大,测定的扩展不确定度为0.0096(k=2),应表示为(99.86±0.96)%。结论通过不确定度的评估,证明了苯磺酸氨氯地平片测定方法的科学、合理,并可以根据各分量的大小优化方法,为实验设计提供数据支持。
Objective To evaluate the uncertainty of the determination of Amlodipine Besylate Tablets by RP-HPLC method. Methods Each component of uncertainty was evaluated by the causality analysis and related data model analysis method, and the combined standard uncertainty and expanded uncertainty were calculated individually. Results The maximal uncertainty component was caused by the purity of reference substance. The expanded uncertainty was 0.009 6 （k=2）, and should be expressed as （99.86 ± 0.96）%. Conclusion The assay method of Amlodipine Besylate Tablets is scientific and reasonable, which could be optimized according to the uncertainty components and the data for the experimental design could be well supplied.
出处
《现代药物与临床》
CAS
2013年第4期535-537,共3页
Drugs & Clinic
