HPLC分析方法验证中有关问题再探讨

分析方法验证以指导原则的形式被收录于《中国药典》，但在验证的执行过程中，不同业者间存在理解和操作方面的差异。本文归纳分析HPLC方法验证实际操作过程中一些亟待探讨的问题：如空白辅料峰的处理、含量均匀度的精密度验证、耐用性验证的项目等，以便在实际工作中顺利按照法规要求进行药物质量控制。

Re-elaboration on the Questions of HPLC Analytical Method Validation

With the increasing pharmaceutical regulations, especially the 2020 edition of the Chinese Pharmacopoeia being effective soon, more and more scientific requirements are required for the validation of HPLC analysis methods. Based on many years of experience, this paper provides practical introduction for the validation of HPLC analysis methods. For example, the processing of blank excipient peaks, the accuracy test of the content uniformity and the selection of robustness items will be discussed in this article. The problems that are easy to be tangled are elaborated in detail, so that it can be applicable to current quality control regulations and requirements.