A Quality-by-Design Methodology for Rapid LC Method Development, Part III

Quality-by-design (QbD) is a methodology gaining widespread acceptance in the pharmaceutical industry. A core tenet of this methodology is the idea of establishing the design space of a product or process as a primary R&D goal. Many articles have been published recently describing the successful application of QbD to process development. By recognizing a liquid chromatography (LC) instrument as a small process-in-a-box, one can readily see the applicability of QbD to LC method development.