Mijo Stanic

This article describes ways to apply quality-by-design principles to build in a more scientific and risk-based multifactorial strategy in the development of an ultrahigh-pressure liquid chromatography (UHPLC) method for omeprazole and its related impurities.

Quality-by-design principles are applied to build in a more scientific and risk-based multifactorial strategy in the development of a UHPLC method for analyzing a drug and its related impurities.