Use of a Proprietary Polar Column Chemistry for the Separation of Nitrosamines in Sartan and Ranitidine Drug Substances

Library Number:
APNT135042716
Part Number:
720006738EN
Author(s):
Margaret Maziarz, Sherri Naughton, and Paul Rainville
Source:
Waters
Content Type:
Application Notes
Content Subtype:
Technical Notes
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This study demonstrates the unique advantages of the Waters XSelect HSS T3 Column Chemistry to separate and identify nitrosamine impurities found in Angiotensin II Receptor Blocker (ARB) and ranitidine drug substances.

The separation was performed on the ACQUITY Arc UHPLC System with photodiode array and ACQUITY QDa Mass Detectors. The XSelect HSS T3 Column, a proprietary reversed-phase column, provided excellent retentivity for nitrosamine impurities and a reliable separation for all analytes. The ACQUITY QDa Mass Detectors allowed for a quick confirmation of peak identity by mass detection. This HPLC method is a suitable starting point for the analysis of nitrosamines or similar compounds


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