Rapid UHPLC Method Development for Omeprazole Analysis in a Quality-by-Design Framework and Transfer to HPLC Using Chromatographic Modeling
A. Schmidt, M. Stanic
LCGC North America, 32, 2, 126-148 (2014)
Keywords: UHPLC, DryLab, QbD, Design Space, Method Development, Method Modeling, Method Transfer, Omeprazole, Impurities
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The aim of this study was 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.
The work presents a quality-by-design–based method development strategy for a method that tests the purity of omeprazole. The scientific and risk-based multifactorial method development strategy uses visual chro- matographic modeling as a fast and easy-to-use development tool. To speed up the method development process, all experiments are performed on a UHPLC system. The final method is successfully transferred to HPLC conditions. Predicted and experimental retention times are verified to confirm accuracy of the model.