目的 對苯磺酸氨氯地平片采用RP-HPLC測定方法的不確定度進(jìn)行評估。方法 采用因果圖分析方法和相關(guān)數(shù)據(jù)模型量化分析方法中各不確定度分量，計(jì)算合成標(biāo)準(zhǔn)不確定度和擴(kuò)展不確定度。結(jié)果 各不確定度分量中由對照品質(zhì)量分?jǐn)?shù)引入的分量最大，測定的擴(kuò)展不確定度為0.009 6（k＝2），應(yīng)表示為（99.86±0.96）%。結(jié)論 通過不確定度的評估，證明了苯磺酸氨氯地平片測定方法的科學(xué)、合理，并可以根據(jù)各分量的大小優(yōu)化方法，為實(shí)驗(yàn)設(shè)計(jì)提供數(shù)據(jù)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.