کیفیت طراحی: اکتشاف چند بعدی از فضای طراحی در روش کروماتوگرافی مایع با کارآیی بالا برای بهبود پایداری قبل از اعتبار سنجی

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.