Introducing a Science-Based Quality by Design Concept to Analytical Methods Development

Although quality by design (QbD) is widely accepted and put into practice for chemical process and formulation development, little attention has been paid to apply it to the analytical methods development and validation. A proposal of applying a science-based QbD approach to a High Performance Liquid Chromatographic (HPLC) analytical method development is presented in this paper. Using the JMP software for DOE design and data analysis, critical method parameters can be identified and thus proper ranges can be set in order to ensure the robustness of the method. This approach allows the robustness to be built into the method during the step of method development.