摘要
目的:利用液质联用法对克洛己新分散片中的降解杂质的结构进行初步推导。方法:采用液质联用法,色谱柱为kromasil C18(4.6mm×250mm,5μm),以0.2%甲酸水溶液(A)-乙腈(B)为流动相进行梯度洗脱,流速0.5m L·min-1。ESI(+)离子源,扫描范围m/z100~2000;对克洛己新分散片加速留样样品进行快速测定,根据克洛己新的降解机理,结合各碎片相对分子质量推测降解途径,从而对降解杂质的结构进行初步推测。结果:对克洛己新分散片中10个超鉴定限的未知降解杂质结构进行初步解析。结论:本实验对克洛己新的杂质谱分析、质量控制具有重要意义。
Objective：To establish an LC_MS method for preliminary identification of the primary degradation impurities in Cefaclor and Bromhexine Hydrochloride Tablets. Methods：The separation was carried out on a kromasil C18 column（4.6mm×250mm, 5 μm） by gradient elution with a mobile phase consisting of 0.2% formic acid aqueous solution （A） and acetonitrile （B） at a flow rate of 0.5mL· min-1.ESI （＋）ion source,scan range m/z 100-2000. Analysising accelerated samples of Cefaclor and Bromhexine Hydrochloride Tablets,The components are identified according to the molecular weight of fragment ions and its degradation mechanism.Results ：The structures of ten impurities were elucidated by LC_MS. Conclusion： The results of this study can be applied in impurity profile analysis, specification research, and quality control of Cefaclor and Bromhexine Hydrochloride Tablets.
作者
伍欣晔
严拯宇
蔡艳
Wu Xinye Yan Zhengyu Cai Yan(Department of Analysis Chemistry, China Pharmaceutical University, Nanjing 210009, China Xiangbei Welman Pharmaceutical Co. Ltd, Nanjing 210033)
出处
《北方药学》
2017年第11期1-3,共3页
Journal of North Pharmacy
关键词
克洛己新分散片
降解杂质
结构推导
液质联用
Cefaclor and Bromhexine Hydrochloride Tablets Degradation impurity Structure indentification LC_MS
