格列吡嗪片高效液相法含量测定结果的不确定度评定

Uncertainty evaluation for HPLC content determination of Glipizide tablets

目的:对格列吡嗪片 HPLC 法含量测定结果的不确定度进行评定。方法:按照2005版中国药典中格列吡嗪片的含量测定方法,通过建立数学模型,对测定结果的不确定度进行评定。结果:分析和量化了各不确定度分量,并合成了标准不确定度和扩展不确定度(K=2)。结论:对照品和供试品的重量不确定度是主要的不确定度来源。

Objective：To evaluate the content uncertainty of Glipizide tablets determined by HPLC method. Method： According to the HPLC method of Chinese Pharmacopia（2005 edition） , mathematic model was established and content uncertainty of Glipizide tablets was evaluated. Results： Each component of uncertainty was analyzed and calculated, while the combined standard uncertainty and expanded uncertainty （ K = 2 ） were estimated. Conclusion ： Weight uncertainty components of reference substances and sample products were main uncertainty factors.