液相色谱法测定皮革中防霉剂含量的方法验证
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摘要
方法验证是检测实验室分析系统可靠的基础,是运用方法标准进行检测分析前的一个必要程序。通过方法验证可以有效避免因方法不合理而导致的不同实验室检验结果之间的显著差异。以"液相色谱法测定皮革中防霉剂含量"为例,通过实验室内验证和实验室间验证相结合,对方法的正确性、可靠性、重复性及方法检出限进行了系统分析。结果表明:该液相色谱法测定皮革中防霉剂含量方法具有良好的合理性、适用性。
Method validation is the reliable basis for testing laboratory analysis system. It is a necessary procedure before the testing by standard. It can effectively avoid significant differences in results between different laboratory due to unreasonable methods. Taking the determination of preservative content in leather by HPLC-DAD as an example, the accuracy, reliability, repeatability and detection limit of the method was analyzed through the combination of laboratory internal verification and laboratory external verification. The results show that the method for determining the content of preservative in leather by high performance liquid chromatography has good rationality and applicability.
Method validation is the reliable basis for testing laboratory analysis system. It is a necessary procedure before the testing by standard. It can effectively avoid significant differences in results between different laboratory due to unreasonable methods. Taking the determination of preservative content in leather by HPLC-DAD as an example, the accuracy, reliability, repeatability and detection limit of the method was analyzed through the combination of laboratory internal verification and laboratory external verification. The results show that the method for determining the content of preservative in leather by high performance liquid chromatography has good rationality and applicability.
引文
[1] GB/T 32465-2015 化学分析方法验证确认和内部质量控制要求[S].
[2] 丁恩峰,高海燕,韩志伟.顶空气相色谱法测定原料药中正丁醇和乙酸乙酯含量的方法验证[J].医药工程设计,2006,4:33-35.
[3] ISO 13365:2010 Determination of preservative content in leather [S].
[4] 马贺伟,熊蒸,陈燕,等.HPLC测定皮革中防霉剂TCMTB的含量[J].中国皮革,2010,39(7):45-47.
[5] Fowler M W,Russell E A,Kruger H I,et al.The extraction and high performance liquid chromatography (HPLC) determination of TCMTB samples of treated wet blue [J].Journal of the Society of Leather Technologists and Chemists 1986,71:100-110.
[6] Nikolaos V,Mark D S,John N L.Analytical methods for the determination of 9 antifouling paint booster biocides in estuarine water samples [J].Chemosphere,1999,38(15):3 503-3 516.
[7] CNAS-GL 02:2014 能力验证结果的统计处理和能力评价指南[S].
[8] GB/T 4086.3-1983 统计分布数值表t分布[S].
[2] 丁恩峰,高海燕,韩志伟.顶空气相色谱法测定原料药中正丁醇和乙酸乙酯含量的方法验证[J].医药工程设计,2006,4:33-35.
[3] ISO 13365:2010 Determination of preservative content in leather [S].
[4] 马贺伟,熊蒸,陈燕,等.HPLC测定皮革中防霉剂TCMTB的含量[J].中国皮革,2010,39(7):45-47.
[5] Fowler M W,Russell E A,Kruger H I,et al.The extraction and high performance liquid chromatography (HPLC) determination of TCMTB samples of treated wet blue [J].Journal of the Society of Leather Technologists and Chemists 1986,71:100-110.
[6] Nikolaos V,Mark D S,John N L.Analytical methods for the determination of 9 antifouling paint booster biocides in estuarine water samples [J].Chemosphere,1999,38(15):3 503-3 516.
[7] CNAS-GL 02:2014 能力验证结果的统计处理和能力评价指南[S].
[8] GB/T 4086.3-1983 统计分布数值表t分布[S].