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引用本文:罗淑青,周征.气相内标法测定甘氨双唑钠中乙醇残留量的不确定度评定[J].中国现代应用药学,2015,32(2):173-177.
LUO Shuqing,ZHOU Zheng.Evaluation of Measurement Uncertainty for the Determination of Alcohol Residue in Glycididazole Sodium by GC Internal Standard Method[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(2):173-177.
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气相内标法测定甘氨双唑钠中乙醇残留量的不确定度评定
罗淑青, 周征
宁波市药品检验所,浙江 宁波 315048
摘要:
目的 建立气相色谱内标法(GC)测定甘氨双唑钠中乙醇残留量的测量不确定度评定方法。方法 通过建立气相色谱内标法测定含量的数学模型,对各个不确定度因素进行评估,计算合成不确定度,最终给出测量结果在95%置信区间下的扩展不确定度。结果 本次实验的甘氨双唑钠中的乙醇残留量测定结果为(0.46±0.01)%。结论 建立的不确定度评定法适用于气相内标法测定药物有机溶剂残留量的不确定度分析。
关键词:  测量不确定度  气相内标法  甘氨双唑钠  乙醇残留量
DOI:
分类号:R917
基金项目:国家药品标准提高研究课题(3-946)
Evaluation of Measurement Uncertainty for the Determination of Alcohol Residue in Glycididazole Sodium by GC Internal Standard Method
LUO Shuqing, ZHOU Zheng
Ningbo Institute for Drug Control, Ningbo 315048, China
Abstract:
OBJECTIVE To evaluate the uncertainty of measurement for determination of alcohol residue in glycididazole sodium by GC internal standard method. METHODS Through establishing GC internal standard method determination mathematical mode, each component of uncertainty was evaluated, from which the combined uncertainty and finally the extended uncertainty were obtained in 95% confidence intervals. RESULTS The determined content of alcohol residue in glycididazole sodium of this test was (0.46±0.01)%. CONCLUSION The established mathematical model is applicable to the uncertainty analysis of GC internal standard method in the determination of the organic solvent residue.
Key words:  measurement uncertainty  GC internal standard method  glycididazole sodium  alcohol residue
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