HPLC分析的全生命周期管理

Life-cycle management of HPLC Analysis

关键词:  HPLC 全生命周期管理  方法验证 验证标准  方法应用

Key words:  HPLC  Life-cycle management  Method validation  Validation criteria  Method application

摘要:

HPLC分析方法的研发-应用过程称之为全生命周期,其可分为连续的6个阶段：方法开发(选择/优化)、方法验证、方法转移、应用准备、常规应用和优化与再评价。在全生命周期的不同阶段,需要特别关注的问题不同。选择/优化HPLC分析方法以满足实际需求为目标；从应用的角度,不仅要考虑方法自身的特性,也要考虑使用者的需求。方法应用时,通过方法转移/确认、系统适用性试验、SOP等,保证每一次实验均达到方法的设计要求；而对分析方法诸验证参数的充分认知,不仅有助于使用者得到准确的检测结果,还可以帮助其得出正确的结论。

Abstract:

The development and application process of a HPLC method is called the life cycle, which can be divided into six consecutive stages: method development (selection/optimization), method validation, method transfer, application preparation, routine application, and optimization/ reevaluation. At the different stages, different problems require pay attention. The selection of HPLC methods should be aimed at meeting the actual needs. From the perspective of application, not only the characteristics of the method itself should be considered, but also the needs of the user. During the application, technology transfer/ verification, system suitability test, SOP, etc. were used to ensure that each experiment met the design requirements of the method. The full understanding of the parameters of the method validation can not only help users to get accurate results, but also help them to draw correct conclusions.