Identification of impurities in nafamostat mesylate using HPLC-IT-TOF/MS: A series of double-charged ions
- Author:
Yuxin ZHANG
1
;
Lufan AN
;
Lin ZHANG
;
Rulin WANG
;
Yuan TIAN
;
Zunjian ZHANG
Author Information
1. Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School,Nanjing,210008,PR China
- Keywords:
Nafamostat mesylate;
Impurity;
Structure identification;
Double-charged ion
- From:
Journal of Pharmaceutical Analysis
2020;10(4):346-350
- CountryChina
- Language:Chinese
-
Abstract:
Nafamostat mesylate is a serine protease inhibitor used in the treatment of acute pancreatitis. The im-purities in nafamostat mesylate, the active pharmaceutical ingredient (API), were profiled via high performance liquid chromatography tandem ion trap coupled with time-of-flight mass spectrometer (HPLC-IT-TOF/MS). The chromatography was performed on an ACE-3 C18 column (200 mm × 4.6 mm, 3μm) using methanol and 0.1％ formic acid in purified water as mobile phase at a flow rate of 1.0 mL/min. The ions were detected by IT-TOF/MS with a full-scan mass analysis from m/z 100 to 800. In total, eleven impurities were detected in nafamostat mesylate API. The impurity profile was estimated based on the HPLC-IT-TOF/MS data, including accurate masses, MSn fingerprints of fragmentation pathways and a series of double-charged ions. Finally, seven impurities were identified and reported for the first time. The results will provide technical support for the quality control and clinical safety of nafamostat mesylate.
