摘要
目的建立毛细管柱气相色谱法同时测定注射用环磷酰胺中甲醇、丙酮、二氯甲烷、二氯乙烷和甲苯5种残留溶剂的分析方法。方法采用HP-5毛细管色谱柱(30m×0.53mm,5μm),FID检测器,以DMF为溶剂。结果 5种残留溶剂均能得到很好的分离。峰面积与质量浓度呈良好的线性关系(r>0.999 8),精密度良好。结论该方法简单、准确、灵敏度高,适用于注射用环磷酰胺中残留溶剂的检测。
Objective To establish gas chromatography（GC）analysis method for the determination of 5residual solvents in cyclophosphamide for injection.Methods HP-5capillary column（30m×0.53 mm,5μm）was used and determined by flame ionization detector（FID）.Dimethyfuran（DMF）was used as the solvent.Results The 5residual solvents were completely separated and good linear relationship was obtained（r〉0.999 8）.Conclusion The established method is simple,accurate,sensitive,and suitable for the determination of cyclophosphamide for injection.
出处
《西北药学杂志》
CAS
2017年第3期299-304,共6页
Northwest Pharmaceutical Journal
基金
2014年国家药品计划抽验项目(编号:111)
关键词
注射用环磷酰胺
气相色谱法
残留溶剂
cyclophosphamide for injection
gas chromatography（GC）
residual solvents
