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

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 (H...

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Autores principales: Zhang, Yuxin, An, Lufan, Zhang, Lin, Wang, Rulin, Tian, Yuan, Zhang, Zunjian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Xi'an Jiaotong University 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7474109/
https://www.ncbi.nlm.nih.gov/pubmed/32923008
http://dx.doi.org/10.1016/j.jpha.2020.03.002
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author Zhang, Yuxin
An, Lufan
Zhang, Lin
Wang, Rulin
Tian, Yuan
Zhang, Zunjian
author_facet Zhang, Yuxin
An, Lufan
Zhang, Lin
Wang, Rulin
Tian, Yuan
Zhang, Zunjian
author_sort Zhang, Yuxin
collection PubMed
description 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 C(18) column (200 mm × 4.6 mm, 3 μm) 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, MS(n) 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.
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spelling pubmed-74741092020-09-11 Identification of impurities in nafamostat mesylate using HPLC-IT-TOF/MS: A series of double-charged ions Zhang, Yuxin An, Lufan Zhang, Lin Wang, Rulin Tian, Yuan Zhang, Zunjian J Pharm Anal Original Article 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 C(18) column (200 mm × 4.6 mm, 3 μm) 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, MS(n) 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. Xi'an Jiaotong University 2020-08 2020-03-03 /pmc/articles/PMC7474109/ /pubmed/32923008 http://dx.doi.org/10.1016/j.jpha.2020.03.002 Text en © 2020 Xi'an Jiaotong University. Production and hosting by Elsevier B.V. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Original Article
Zhang, Yuxin
An, Lufan
Zhang, Lin
Wang, Rulin
Tian, Yuan
Zhang, Zunjian
Identification of impurities in nafamostat mesylate using HPLC-IT-TOF/MS: A series of double-charged ions
title Identification of impurities in nafamostat mesylate using HPLC-IT-TOF/MS: A series of double-charged ions
title_full Identification of impurities in nafamostat mesylate using HPLC-IT-TOF/MS: A series of double-charged ions
title_fullStr Identification of impurities in nafamostat mesylate using HPLC-IT-TOF/MS: A series of double-charged ions
title_full_unstemmed Identification of impurities in nafamostat mesylate using HPLC-IT-TOF/MS: A series of double-charged ions
title_short Identification of impurities in nafamostat mesylate using HPLC-IT-TOF/MS: A series of double-charged ions
title_sort identification of impurities in nafamostat mesylate using hplc-it-tof/ms: a series of double-charged ions
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7474109/
https://www.ncbi.nlm.nih.gov/pubmed/32923008
http://dx.doi.org/10.1016/j.jpha.2020.03.002
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