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