质量分析方法验证中检出限和定量限测定方法探讨

Discussion on the Detecting Methods for Limit of Detection and Limit of Quantification in Validation of Analytical Method

分析、比较了IUPAC,ICH及国内其他分析检测领域关于检出限和定量限的概念和测定方法,试验比较了几种测定方法的差异,可为中药质量分析方法验证中检出限和定量限的测定方法提供参考。

The concepts and detecting methods for Limit of Detection and Limit of Quantification were discussed based on the analysis and comparison with IUPAC, ICH and the other related fields domestic. Several different detection methods were compared by the test experiments. The suggestions were put forward for the provision of the detecting methods.