6- https://doi.org/10.1007/978-1-4419-0889-6_22
Introducing a Science-Based Quality by Design Concept to Analytical Methods Development
- Oct 20, 2009
- Jianmei Kochling +2 more
Abstract
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.
- # Quality By Design
- # Critical Method Parameters
- # Analytical Development
- # Analytical Methods Development
- # High Performance Liquid Chromatographic
- # Liquid Chromatographic Analytical Method
- # Liquid Chromatographic Method Development
- # Formulation Development
- # Chemical Process Development
- # High Performance Liquid Chromatographic Method
