Using an innovative Quality-by-Design approach for development of a stability indicating UHPLC method for ebastine in the API and pharmaceutical formulations

► Using an innovative Quality by Design approach for development of a stability indicating UHPLC method for ebastine. ► A Design Space - a volume in which the method is robust - is defined and visualized. ► The predicted retention times and resolution values are in excellent agreement with experimental values. ► The method was fully validated in compliance with ICH guidelines. ► A robustness study was performed by varying six chromatographic parameters.