HPLC测定舒美宁胶囊中大豆苷、染料木苷的不确定度分析

Uncertainty analysis for daidzi and genistin in Shumeining Capsule by HPLC

目的:建立HPLC法同时测定舒美宁胶囊中大豆苷、染料木苷的不确定度评定方法。方法:采用HPLC法测定舒美宁胶囊中大豆苷、染料木苷的含量,建立数学模型,分析不确定度来源,最后计算扩展不确定度。结果:舒美宁胶囊中大豆苷的报告不确定度为±0.248%(k=2);染料木苷的报告不确定度为±0.224%(k=2)。结论:本方法建立的数学模型合理、可靠,可用于舒美宁胶囊中大豆苷、染料木苷含量的不确定度评定。

Objective:To establish a HPLC method to determine the content of daidzi and genistin in Shumeining capsules for uncertainty analysis.Methods:The content of daidzein and genistein in Shumenin capsules was determined by HPLC.The mathematical model was established and the source of uncertainty was analyzed.Finally the extended uncertainty was calculated.Results:The uncertainty in the report of daidzein in Shumeining capsule was±0.248%(k=2)and that of genistein was±0.224%(k=2).Conclusion:The mathematical model established by this method is reasonable and reliable,and can be used to evaluate the uncertainty of daidzein and genistein in Shumenin capsules.