化学分析方法验证和确认的应用研究

分析方法的验证/确认是实验室引进新方法时必做的工作,也是实验室技术工作的重点和难点之一。对实验室采用分析方法的验证和确认工作进行归纳总结,详述了分析方法选择性、测量范围、线性范围、检出限和定量限、精密度、准确度的验证/确认方法及结果判定方式。适用于实验室引进的标准方法(包括标准变更)和非标准方法(实验室设计/制定的方法、超出预定范围使用的标准方法、扩充和修改过的标准方法)的验证和确认。

Application research of verification and validation of chemical analytical methods

The verification/validation of the analysis method is a necessary work when the new method is introduced into the laboratory, and it is also one of the key and difficult points in the laboratory technical work. In this paper, the verification and validation of analytical methods adopted in the laboratory are summarized. The methods of verification/validation and result determination of selectivity, measurement range, linear range, detection limit and quantitative limit, precision and accuracy of analytical method are discussed in detail. It is suitable for verification and validation of standard methods introduced in laboratory (including standard change) and non-standard methods (laboratory design/formulation method, standard method used beyond the intended range, extended and modified standard method).