A highly sensitive LC-MS/MS method for the determination and quantification of a recently identified <i>N</i>-nitrosamine impurity in the sitagliptin phosphate monohydrate active pharmaceutical ingredient
Zhen Wang, Shujun Hu, Xiaoying Wu, Zuwei He, Chun-Long Ke, Miaomiao Hu
Abstract
A fully validated LC-MS/MS method was developed for quantification of 7-nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine (NTTP) in sitagliptin phosphate monohydrate at LOQ of 0.098 ppm.
Topics & Concepts
ChemistryAmmonium formateChromatographySitagliptin PhosphateSitagliptinAmmonium dihydrogen phosphateElectrospray ionizationSelected reaction monitoringMass spectrometryAcetonitrileActive ingredientBioanalysisAnalytical Chemistry (journal)Tandem mass spectrometryOrganic chemistryMetforminDiabetes mellitusFertilizerMedicineBiologyBioinformaticsEndocrinologyAnalytical Chemistry and ChromatographyMass Spectrometry Techniques and ApplicationsAnalytical Methods in Pharmaceuticals