Quantitative Study of Impurities in Bedaquiline Fumarate: Identification and Characterization of Its Three Degradation Products Using HPLC, LC/ESI-MS, and NMR Analyses

• Main Authors: Xiao-Wen Zhang (Author), Gang-Long Jiang (Author), Guo-Jing Li (Author), Xiao-Yan Chen (Author), Ai-Nan Zhou (Author), Yu Liu (Author)
• Format: Book
• Published: Georg Thieme Verlag KG, 2023-03-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract The study aimed to establish a high-performance liquid chromatography (HPLC) method for the quantitative analysis of the related substances of bedaquiline fumarate. Nuclear magnetic resonance and mass spectrometry were used for characterization and assay. A chromatographic method was used f...