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作 者:李荣生[1] 王玉[2] 伍乃英[2] 冯有龙[2] 曹玲[2]
机构地区:[1]江苏省计划生育药具管理站,江苏南京210009 [2]江苏省食品药品检验所,江苏南京210008
出 处:《药学进展》2010年第12期565-570,共6页Progress in Pharmaceutical Sciences
摘 要:目的:建立毛细管柱气相色谱(GC)法测定十滴水中乙醇含量的不确定度分析方法,并与填充柱GC法测定结果的分散性进行比较。方法:通过建立两种GC法测定乙醇含量的数学模型,找出影响不确定度的因素,并对各不确定度分量进行评估、计算,由此计算合成不确定度,最终得出测量结果的扩展不确定度。结果:毛细管柱和填充柱GC法测定结果的合成不确定度分别为1.8×10-2和2.2×10-2;扩展不确定度分别为0.036和0.044;乙醇含量测定结果分别为(63.28±0.04)%和(63.59±0.04)%。结论:毛细管柱气相色谱法测定乙醇含量的结果的不确定度与填充柱法相近,可用于测定药物含量的不确定度分析。Objective:To establish a capillary GC method for evaluating uncertainty in assay of ethanol in Shi-Di-Shui tincture,and then to compare the uncertainty results by determination by GC method with packed column.Methods:The factors affecting the uncertainty were deduced by establishing mathematical model for the determination by capillary and packed column GC method.Each component of uncertainty was evaluated and calculated,from which the combined uncertainty and then the extended uncertainty were obtained.Results:The combined uncertainty for determination by capillary and packed column GC method was 1.8 ×10-2 and 2.2×10-2,the extended uncertainty was 0.036 and 0.044,and the determined content of ethanol was(63.28±0.04)% and(63.59±0.04)%,respectively.Conclusion:The results of the uncertainty evaluation in assay of ethanol by capillary GC is similar to those obtained by packed column GC,and the established method is applicable to the uncertainty analysis in assay of drugs.
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