In silico robustness testing of a compendial HPLC purity method by using of a multidimensional design space build by chromatography modeling-Case study pramipexole

- Innovative QbD-based approach for robustness testing of a compendial HPLC method.
- A Design Space was constructed to study the robustness in silico.
- Required peak resolution of 2.0 could not be reached in all experiments.
- After adjusting the gradient time the requirements were fulfilled.
- A separate “Eluent Design Space” study was performed.