Identification and characterization of related substances in EVT-401 by hyphenated LC–MS techniques / 药物分析学报
Journal of Pharmaceutical Analysis
; (6): 223-230, 2017.
Article
in Zh
| WPRIM
| ID: wpr-671260
Responsible library:
WPRO
ABSTRACT
A sensitive and selective method was developed for the separation and characterization of related substances (RSs) in EVT-401 by hyphenated LC–MS techniques. Complete separation of the RSs was achieved with an Inertsil ODS-SP column (250 mm×4.6 mm, 5 μm) by linear gradient elution using a mobile phase consisting of 0.2% formic acid solution, methanol and acetonitrile. EVT-401 was found to be susceptible to acid, alkaline and oxidative stresses, while relatively stable under photolytic and thermal dry stress conditions. Fourteen RSs including six process-related substances and eight degradation products were detected and identified in EVT-401 with positive ESI high-resolution TOF-MS analysis of their parent ions and the corresponding product mass spectra elucidation, and some of them were further verified by chemical synthesis and NMR spectroscopy. The specific LC–MS method developed for separation, identification and characterization of RSs is valuable for EVT-401 manufacturing process optimization and quality control.
Full text:
1
Index:
WPRIM
Type of study:
Diagnostic_studies
Language:
Zh
Journal:
Journal of Pharmaceutical Analysis
Year:
2017
Type:
Article