Chapter 5 - Analytical quality by design for liquid chromatographic method development

Abstract

Analytical quality by design (AQbD) has now been considered as an indispensable element for the analytical testing and development of robust analytical methods. Since the inception of the concept, it has proven its worth in developing the drug products with robust performance. Notwithstanding the benefits of AQbD in product development, it has versatile applications in analytical development. Within analytical science, the liquid chromatographic methods are increasingly used for routine pharmaceutical analysis and quality assessment of the drug products. Such methods primarily include high-performance liquid chromatography, ultra-performance liquid chromatography, and ultra-fast liquid chromatography. The critical understanding of the analytical method performance essentially requires systematic optimization of the critical method parameters for attaining enhanced robustness and performance to support the product development through the life cycle. AQbD typically provides benefits by reducing the time, resources, and efforts for developing robust liquid chromatographic methods with applicability in the analysis of drug substances, degradation products, impurities, and metabolites.