Identification of impurities in nafamostat mesylate using HPLC-ITTOF/MS:A series of double-charged ions  

作　　者：Yuxin Zhang Lufan An Lin Zhang Rulin Wang Yuan Tian Zunjian Zhang 

机构地区：[1]Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School,Nanjing,210008,PR China [2]Jiangsu D&R Pharmaceutical Corporation,Taizhou,225312,PR China [3]Department of Pharmacy,General Hospital Tianjin Medical University,Tianjin,300052,PR China [4]Key Laboratory of Drug Quality Control and Pharmacovigilance(Ministry of Education),China Pharmaceutical University,Nanjing,210009,PR China

出　　处：《Journal of Pharmaceutical Analysis》2020年第4期346-350,共5页药物分析学报（英文版）

基　　金：This work was financially supported by the National Major Science and Technology Projects of China(2017ZX09101001);the Double First-Class University Project(CPU2018GY33).

摘　　要：Nafamostat mesylate is a serine protease inhibitor used in the treatment of acute pancreatitis.The impurities 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 mm4.6 mm,3 mm)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.

关 键 词：Nafamostat mesylate IMPURITY Structure identification Double-charged ion 

分 类 号：R927.2[医药卫生—药学]