Analytical Quality-by-Design approach for HPLC analysis of pharmaceutical mixtures: case studies

Analytical Quality-by-Design (AQbD) is a methodical approach to method development, which is relatively novel to the analytical scientists. It oversees every phase of the analytical procedure's lifecycle by defining the Analytical Target Profile (ATP), pinpointing critical method parameters (CMPs) or factors, and choosing critical method attributes (CMAs) or responses. Utilizing screening and response-surface experimental designs enables the identification and optimization of significant factors through statistical analysis. It helps establish the design space or Method Operable Design Region (MODR) to ensure robust method performance. This review discusses the theoretical foundation of AQbD approach for method development and presents its most recent application illustrated in some case studies on HPLC analysis of pharmaceutical mixtures.