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

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… CONTINUE READING