在UHPLC中通过设计增强药品分析与分析质量:对方法创新的审查 (2014-2025)
1Department of Quality Assurance, Parul Institute of Pharmacy & Research, Parul University, Vadodara, India.
Critical reviews in analytical chemistry
|June 12, 2025
概括
通过设计分析质量 (AQbD) 增强了用于制药分析的超高性能液体染色学 (UHPLC). 本综述巩固了使用风险评估和优化策略进行强大,高效和符合监管的UHPLC开发的方法.
科学领域:
- 分析化学 分析化学
- 制药科学 制药科学
背景情况:
- 通过设计 (AQbD) 的分析质量原则在制药方法开发中越来越多地被采用.
- 专注于AQbD在超高性能液态染色学 (UHPLC) 的应用的专门审查是有限的.
- 现有的文献主要涵盖一般的AQbD或特定的药物应用,而不是UHPLC专注的评估.
研究的目的:
- 系统地审查和巩固用于制药分析的AQbD驱动的UHPLC的方法和进展.
- 弥合UHPLC中关于AQbD的专门文献上的差距.
- 为监管合规,生命周期管理和未来的UHPLC开发提供关键的见解.
主要方法:
- 在UHPLC中巩固报告的风险评估方法,实验设计和优化.
- 使用选设计 (例如,普莱克特-伯曼设计) 和风险评估工具 (例如,石川图) 识别关键方法参数 (CMP).
- 使用响应表面方法 (RSM) 优化UHPLC性能,并检查固定相,移动相组成和流量等因素.
主要成果:
- 经常报道以乙烯为桥梁的混合型八甲基列和用酸或酸的水-酸移动相.
- 梯度化对于复杂的分离是常见的,优化的流速 (0.2-0.5毫升/分钟) 提高了效率和可持续性.
- 定义方法可操作设计区域 (MODR) 是通过系统的 AQbD 方法建立的.
结论:
- AQbD为制药行业开发和优化UHPLC方法提供了一个强大的框架.
- 本综述提供了对UHPLC应用的AQbD策略的全面概述,帮助研究人员和开发人员.
- 这些发现支持加强监管合规性,方法生命周期管理,以及制药分析的进步.
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