Zhang Yuxin, An Lufan, Zhang Lin, Wang Rulin, Tian Yuan, Zhang Zunjian
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, PR China.
Jiangsu D&R Pharmaceutical Corporation, Taizhou, 225312, PR China.
J Pharm Anal. 2020 Aug;10(4):346-350. doi: 10.1016/j.jpha.2020.03.002. Epub 2020 Mar 3.
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 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 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 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.
甲磺酸萘莫司他是一种用于治疗急性胰腺炎的丝氨酸蛋白酶抑制剂。通过高效液相色谱串联离子阱与飞行时间质谱仪（HPLC-IT-TOF/MS）对活性药物成分（API）甲磺酸萘莫司他中的杂质进行了剖析。色谱分析在ACE-3 C柱（200 mm×4.6 mm，3μm）上进行，以甲醇和0.1%甲酸的纯化水溶液为流动相，流速为1.0 mL/min。通过IT-TOF/MS进行离子检测，全扫描质量分析范围为100至800。在甲磺酸萘莫司他API中总共检测到11种杂质。基于HPLC-IT-TOF/MS数据评估了杂质概况，包括精确质量、碎片途径的质谱指纹图谱以及一系列双电荷离子。最后，首次鉴定并报道了7种杂质。这些结果将为甲磺酸萘莫司他的质量控制和临床安全性提供技术支持。
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