REVERSED-PHASE LIQUID CHROMATOGRAPHIC METHOD DEVELOPMENT IN AN ANALYTICAL QUALITY BY DESIGN FRAMEWORK

Abstract

The Analytical Quality by Design (AQbD) concept is demonstrated in the development of a stability-indicating HPLC method for an immediate release dosage form. The AQbD workflow is discussed and demonstrated with a systematic three stage liquid chromatograph method development (wave 1 through wave 3), risk assessment (RA), design of experiments (DOEs), and assessment of the data to provide a method operable design region (MODR) and center point for the method. The use of AQbD workflows streamlines the development of methods as compared to traditional approaches. With the addition of systematic RAs and DOEs, robust and rugged analytical methods result. These methods will have fewer issues and failures throughout the lifecycle due to the knowledge gained via the AQbD process and defining chromatographic set points away from the edges of failure.