The variability of AOAC methods of analysis as used in analytical pharmaceutical chemistry.
The variability of AOAC methods of analysis as used in analytical pharmaceutical chemistry.
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DOI：
10.1093/jaoac/60.6.1355
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发表时间：
1977-11
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影响因子：
--
通讯作者：
W. Horwitz
中科院分区：
文献类型：
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作者：
W. Horwitz
药物分析化学通常处理含有 0.1% 至 100% 活性成分的制剂的分析，使用的方法的再现性（实验室间变异性）约为 2.5%，重复性（实验室内变异性）约为该数值的一半。可达到的最佳实验室间精度约为 1.0%，实验室内精度约为 0.5%。根据现有结果，自动化方法似乎并不比手动方法更精确，尽管研究显示外围数据点较少。重复（最好是盲目重复）应始终在实验室间协作研究中进行，以获得重要信息，以确定是否应集中精力改进方法本身或实验室的性能和应用方法的分析。
Pharmaceutical analytical chemistry, which ordinarily deals with the analysis of formulations containing from 0.1 to 100% of active ingredient, uses methods with a reproducibility (between-laboratory variability) of about 2.5% and a repeatability (within-laboratory variability) of about half that amount. The best between-laboratory precision attainable appears to be about 1.0% and within-laboratory precision, about 0.5%. On the basis of the results available, automated methods do not appear to be any more precise than manual methods, although the studies show fewer outlying data points. Replicates (preferably blind ones) should always be conducted in a collaborative interlaboratory study in order to obtain the important information as to whether efforts should be concentrated on improving the method itself or on the performance of laboratories and analysis in applying it.