Automated QbD-Based Method Development and Validation of Oxidative Degraded Atorvastatin
20 Aug 2014
In this Application Note, an Agilent 1200 Infinity Series LC Method Development System was coupled with the Fusion QbD Automated QbD Method Development and Validation Software to develop and validate a method for the separation of Atorvastatin API from its oxidative degradants. Method development was performed by screening and optimizing method parameters using separate DOE designs5, 6, 7. The method was validated by multivariate robustness designs.