Applying A Software-Assisted Analytical QbD Approach For The Analysis Of Formoterol, Budesonide, And Related Compounds By UPLC-MS

By Fadi L. Alkhateeb and Paul D. Rainville, Waters Corporation

Analytical method performance is critical to ensure the quality, safety, and efficacy of pharmaceutical products. Two of the most commonly used ones are One Factor at a Time (OFAT) and Analytical Quality by Design (AQbD).

Analytical method performance is critical to ensure the quality, safety, and efficacy of pharmaceutical products. Currently, there are several approaches for method development in the analytical realm. Two of the most commonly used ones are One Factor at a Time (OFAT) and Analytical Quality by Design (AQbD). This approach is not very comprehensive, and the separations are often sub-optimal in terms of resolution, peak shape, and robustness.

In the AQbD approach, however, a more comprehensive, systematic, and risk-based strategy that starts with predefined objectives is used for method development. In this approach, multiple parameters and settings are explored to provide a broad knowledge about the impact of the studied factors on the method performance. This knowledge is used to establish the method operable design region (MODR), which corresponds to the multi-dimensional combination of variables that have been verified to meet the method performance criteria. The outcome of this approach is a fit-for-purpose, well-designed, understood, and robust method that reliably delivers the expected performance throughout its lifecycle.

This application note focuses mainly on exploring the analytical potential of the AQbD approach for achieving high-performance separations of formoterol, budesonide, and its related compounds. Several key chromatographic parameters are investigated for their effect on the efficiency of the separations, and the findings are presented and discussed. Fusion QbD will be used as an AQbD software for method development in this application note.