Molnár-Institute for applied chromatography, Berlin, Germany.
J Chromatogr A. 2012 Apr 6;1232:218-30. doi: 10.1016/j.chroma.2011.12.041. Epub 2011 Dec 20.
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.
稳健的 HPLC 分离可减少分析失败，更好地进行方法转移，并确保质量。这项工作按照质量源于设计的原则，系统地开发了一种最优、稳健、快速的 UHPLC 方法，用于同时测定滴眼剂样品中两种 API 及其杂质的含量。色谱软件用于有效地生成设计空间（方法可操作设计区域），随后用于确定最终方法条件，并在验证之前评估稳健性。
