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Application of online liquid chromatography/quadrupole time-of-flight electrospray ionization tandem mass spectrometry for structural characterization of linagliptin degradation products and related impurities.

Amrej Singh YadavDivya DornalaDebasish SwainAishwarya PrabhaGananadhamu Samanthula
Published in: Rapid communications in mass spectrometry : RCM (2021)
A reversed-phase high-performance liquid chromatography method was developed and validated for the separation of the 12 degradation products and 6 process-related impurities. Structural characterization of all impurities was carried out using fragmentation pathways obtained from tandem mass spectrometry. The method was sufficiently sensitive and reproducible for quality control of linagliptin and for further research studies.
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