Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
7631985 | Journal of Pharmaceutical and Biomedical Analysis | 2013 | 10 Pages |
Abstract
⺠Using an innovative Quality by Design approach for development of a stability indicating UHPLC method for ebastine. ⺠A Design Space - a volume in which the method is robust - is defined and visualized. ⺠The predicted retention times and resolution values are in excellent agreement with experimental values. ⺠The method was fully validated in compliance with ICH guidelines. ⺠A robustness study was performed by varying six chromatographic parameters.
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Alexander H. Schmidt, Imre Molnár,