Recently, the use of the Analytical Quality by Design (AQbD) approach for method development has been increasingly accepted in the industrial, academic and regulatory circles. This is because it is a comprehensive, systematic, and risk-based approach that provides a broad knowledge about the impact of the critical chromatographic parameters on the method performance. The present work aims at employing the AQbD principles in developing an Ultra High Performance Liquid Chromatography-Mass Spectrometry method (UHPLC-MS) for the analysis of Budesonide, Formoterol, and related compounds in Symbicort®. The different AQbD method development stages including, screening, optimization, and verification will all be demonstrated. The advantages of using mass spectrometry for detecting and tracking the analytes of interest will also be presented and discussed.
1. Explain the Analytical Quality by Design Principles.
2. Discuss the benefits of using specialized software for rapid and robust method development.