title: Identification, characterization, and high-performance liquid chromatography quantification of process-related impurities in vonoprazan fumarate.
abstract: High-performance liquid chromatography analysis of vonoprazan fumarate, a novel proton pump inhibitor drug revealed six impurities. These were identified by liquid chromatography with mass spectrometry. Further, the structures of the impurities were confirmed by synthesis followed by characterization by mass spectrometry, NMR spectroscopy, and infrared spectroscopy. On the basis of these data and knowledge of the synthetic scheme of vonoprazan fumarate, the previously unknown impurity was identified as 1-[5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methyldimethylamine, which is a new compound. The possible mechanisms by which these impurities were formed were also discussed. A high-performance liquid chromatography method was optimized in order to separate, selectively detect, and quantify all process-related impurities of vonoprazan fumarate. The presented method has been validated in terms of linearity, limits of detection, and quantification, and response factors and, therefore, is highly suitable for routine analysis of vonoprazan fumarate related substances as well as stability studies.
authors: School of Pharmaceutical Sciences, Nanjing Tech University, Nanjing, P.R. China.
authors: Lei
authors: L
authors: Liu
authors: School of Pharmaceutical Sciences, Nanjing Tech University, Nanjing, P.R. China.
authors: Na
authors: N
authors: Cao
authors: School of Pharmaceutical Sciences, Nanjing Tech University, Nanjing, P.R. China.
authors: Xingling
authors: X
authors: Ma
authors: College of Biotechnology and Pharmaceutical Engineering, Nanjing Tech University, Nanjing, P.R. China.
authors: Kaihe
authors: K
authors: Xiong
authors: College of Biotechnology and Pharmaceutical Engineering, Nanjing Tech University, Nanjing, P.R. China.
authors: Lili
authors: L
authors: Sun
authors: School of Pharmaceutical Sciences, Nanjing Tech University, Nanjing, P.R. China.
authors: Qiaogen
authors: Q
authors: Zou
mesh_terms: D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D015394:Molecular Structure; D011758:Pyrroles / Q000138:chemical synthesis / Q000737:chemistry*; D013449:Sulfonamides / Q000138:chemical synthesis / Q000737:chemistry*
chemical_list: C552956:1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; D011758:Pyrroles; D013449:Sulfonamides
keywords: High-performance liquid chromatography; Process-related impurities; Vonoprazan fumarate