HPLC法测定维生素B_6片含量的不确定度分析  

Assessment of uncertainty in determination of Vitamin B_6 Tablets by HPLC

作　　者：朱清丽 柯红梅 谭艳萍 王立鹏 

机构地区：[1]安康市食品药品检验检测中心,安康725000

出　　处：《西北药学杂志》2014年第5期466-469,共4页Northwest Pharmaceutical Journal

摘　　要：目的通过对HPLC法-外标法测定维生素B6片含量进行不确定度评定,为建立有效的质量控制方法提供参考。方法通过建立HPLC法测定数学模型,分析测量过程,确定不确定度来源、合成不确定度。结果合成不确定度uc=0.49%,扩展不确定度U=0.98%(k=2)。结论影响测量结果不确定度的主要因素为测量重复性、对照品称样量等。Objective To assess the uncertainty in determination of Vitamin B6 Tablets by HPLC external standard method ,and to provide a reference for the establishment of effective quality control method .Methods By establishing HPLC mathematical mod-el ,the sources of uncertainty were evaluated .Results Synthetic uncertainty uc was 0 .49% ,and the expanded uncertainty U was 0 .98% （k=2） .Conclusion The measurement repetition ,and reference sample quantity etc were the major sources of uncertainty .

关 键 词：维生素B6片 含量 HPLC 不确定度 

分 类 号：R917[医药卫生—药物分析学]