Quality by Design: Multidimensional exploration of the design space in high performance liquid chromatography method development for better robustness before validation

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• 作者：K. Monks^a ; ^{kate.monks@molnar-institute.com} ; I. Molná ; r^a ; H.-J. Rieger^a ; B. Bogá ; ti^b ; E. Szabó ; ^b
• 关键词：Robustness ; Design space ; Validation ; Chromatography modeling software ; Quality by Design (QbD)
• 刊名：Journal of Chromatography A
• 出版年：2012
• 期刊代码：47_00219673
• 类别：ch
• 出版时间：6 April, 2012
• 卷：1232
• 期：Complete
• 页码：218-230
• 文件大小：2380 K

摘要

Robust HPLC separations lead to fewer analysis failures and better method transfer as well as providing an assurance of quality. This work presents the systematic development of an optimal, robust, fast UHPLC method for the simultaneous assay of two APIs of an eye drop sample and their impurities, in accordance with Quality by Design principles. Chromatography software is employed to effectively generate design spaces (Method Operable Design Regions), which are subsequently employed to determine the final method conditions and to evaluate robustness prior to validation.