Highly Sensitive and Robust UPLC-MS/MS Quantification of Nitrosamine Impurities in Sartan and Ranitidine Drug Substances

Library Number:
APNT135042796
Part Number:
720006751EN
Author(s):
Lindsay Hatch, Mary Lame, Dave Higton, Paul Rainville, and Gordon Fujimoto
Source:
Waters
Content Type:
Application Notes
Content Subtype:
Technical Notes
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This technology brief demonstrates a highly sensitive and robust LC-MS/MS quantification method for six nitrosamine impurities (NDMA, NDEA, NEIPA, NDIPA, NDBA, and NMBA) in solutions containing irbesartan, losartan, valsartan (sartans), and ranitidine drug substances.

A single UPLC-MS/MS method was successfully developed for the accurate, robust, and highly sensitive quantification of six nitrosamine impurities, achieving LLOQs of 0.1 ng/mL using the ACQUITY UPLC I-Class PLUS and the Xevo TQ-XS Tandem Quadrupole Mass Spectrometer. The ACQUITY HSS T3 Column provided excellent retentivity and selectivity for six nitrosamine impurities. This method offers a practical starting point for high sensitivity quantification of nitrosamines or similar compounds.


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