Validation of a Method for the Separation of Ziprasidone and Its Degradants using Empower 2 with Method Validation Manager (MVM)

Library Number:
APNT134644578
Part Number:
720004077en
Author(s):
Mia Summers and Kenneth J. Fountain
Content Type:
Application Notes
Content Subtype:
Application Notes
Related Products:
 
 
 

In this application note, the validation of a method developed for the separation of ziprasidone and impurities from a forced degradation is demonstrated using Empower 2 with Method Validation Manager (MVM).  While a variety of tests can be set-up using MVM, the validation tests performed in this example include accuracy, linearity, robustness, repeatability, limit of detection (LOD) and limit of quantitation (LOQ) determinations. Intermediate precision was also tested using a Method Validation Kit, to ensure reliability of the method across three different batches of the same column chemistry.


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