| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 7630893 | Journal of Pharmaceutical and Biomedical Analysis | 2014 | 11 Pages |
Abstract
- 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.
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Alexander H. Schmidt, Mijo Stanic, Imre Molnár,