摘要
目的建立一种液质联用鉴别头孢美唑钠中有关物质及其质谱裂解规律的方法.方法采用ODS-C18色谱柱,1%甲酸水溶液-乙腈梯度洗脱.研究头孢美唑钠及有关物质色谱保留行为、一级质谱图和二级质谱碎片信息,推断化学结构.结果共检测出5个有关物质.结论结果表明该方法高效、准确,特别适用于药品质量控制.
Objective The identification and characterization of process related impurities in cefmetazole sodium for injection using LCMS-IT-TOF method was established. Methods An ODS-C18 separation column and gradient elution of 1% formic acid-acetonitrile were employed. The retention behavior, MS/MS spectrum of cefmetazole sodium and its related impurities were studied. Results There were 5 related substances were determined. Conclusion The results show that this method was effective and more accurate, especially suitable in drug quality control.
作者
朱峰
杨贵方
杨波
樊好飞
肖文礼
赵振东
刘启兵
薛丽
ZHU Feng;YANG Gui-fang;YANG Bo(Hainan GM Sanyo Pharmaceutical Co., Ltd., Haikou 570312;Hainan Zhongji Pharmaceutical Technology Limited Company, Haikou, 570311;School of Basic Medicine and Life Sciences, Hainan Medical College, Haikou,571199;Hainan University Analysis and Testing Center, Haikou, 570208;Clinical Pharmacy Research Center, the First Affiliated Hospital of Hainan Medical College, Haikou,570203, China)
出处
《中国处方药》
2019年第8期1-4,共4页
Journal of China Prescription Drug
基金
海南省重点科技计划项目（ZDYF2018154）
海口市重点科技计划项目（2017-010)
关键词
头孢美唑钠
有关物质
液质联用
Cefmetazole sodium
Related impurities
LCMS-IT-TOF
