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HPLC法测定葛根素注射液含量不确定度评定 被引量:2

Uncertainty Analysis Assay for Puerarin Injection with HPLC
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摘要 目的:建立HPLC法测定葛根素注射液含量的不确定度分析方法。方法:通过建立HPLC含量测定法的数学模型,找出影响不确定度的因素并对各个不确定度分量进行评定。结果:计算各分量的相对标准不确定度,由此计算合成不确定度及扩展不确定度(P=95%,K=2)。结论:测量不确定度可用于对葛根素注射液含量测定结果的评定。 Objective: To establish an uncertainty analysis method for assay of puerarin injection with HPLC. Method: The mathematic model was established with HPLC identified the influence factors impact uncertainty and each component of uncertainty was also evaluated. Result: Each component of nucertainty was calculated by analyzed the various variable parameters in the procedure, the combined uncertainty and expanded uncertainty were finally obtained. Conclusion : The mathematic model of uncertainty is establish for applicable to evaluate the accuracy of assay of puerain injection.
作者 刘洪海 李宇
出处 《中国药师》 CAS 2009年第9期1256-1258,共3页 China Pharmacist
关键词 葛根素注射液 含量 HPLC法 测量不确定度 Puerarin injection Content HPLC Uncertainty of mersurement
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  • 1ChP(中国药典).2005.Vol Ⅰ(一部):173
  • 2General Administration of Quality Supervision,Inspection and Quarantine of the People's Republic of China(国家质量技术监督局).Evaluation and expression of uncertainty in measurement(测量不确定度评定与表示),JJF1059-1999.Beijing(北京):China Metralogy Press(中国计量出版社),1999
  • 3China National Accreditation Board for Laboratories(中国实验室国家认可委员会).Guide to evaluation of uncertainty in chemical analysis(化学分析中不确定度的评估指南).Beijing(北京):China Metrology Press(中国计量出版社),2002.75
  • 4JJF 1059-1999.测量不确定度评定与表示[S],1999.

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