Abstract:
The development-application-optimization/reevaluation 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, standard operating procedure and so on 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.