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 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, 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.

甲磺酸萘法莫他是一种丝氨酸蛋白酶抑制剂，用于治疗急性胰腺炎。通过高效液相色谱串联离子阱和飞行时间质谱仪（HPLC-IT-TOF / MS）对纳法莫他甲磺酸盐（活性药物成分（API））中的杂质进行了分析。色谱在ACE-3 C ₁₈色谱柱（200 mm×4.6 mm，3μm）上进行，使用甲醇和0.1％甲酸的纯水作为流动相，流速为1.0 mL / min。通过IT-TOF / MS对离子进行了检测，并进行了m / z 100至800的全扫描质量分析。在萘法莫他甲磺酸盐API中总共检测到11种杂质。根据HPLC-IT-TOF / MS数据估算杂质分布，包括准确质量数MS ⁿ碎裂路径和一系列双电荷离子的指纹。最终，首次鉴定并报告了七个杂质。结果将为甲磺酸萘法莫他的质量控制和临床安全性提供技术支持。