| 注射用环磷酰胺中残留溶剂的测定 |
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| 引用本文： | 艾芸,张凡,张亚锋,李卓,王永姣,雷成康.注射用环磷酰胺中残留溶剂的测定[J].西北药学杂志,2017(3):299-304. |
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| 作者姓名： | 艾芸 张凡 张亚锋 李卓 王永姣 雷成康 |
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| 作者单位： | 西安市食品药品检验所,西安,710054 |
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| 基金项目： | 2014年国家药品计划抽验项目(111) |
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| 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。
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| 关 键 词： | 注射用环磷酰胺 气相色谱法 残留溶剂 |
Determination of residual solvents in cyclophosphamide for injection |
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| AI Yun,ZHANG Fan,ZHANG Yafeng,LI Zhuo,WANG Yongjiao,LEI Chengkang.Determination of residual solvents in cyclophosphamide for injection[J].Northwest Pharmaceutical Journal,2017(3):299-304. |
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| Authors: | AI Yun ZHANG Fan ZHANG Yafeng LI Zhuo WANG Yongjiao LEI Chengkang |
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| Abstract: | Objective To establish gas chromatography (GC) analysis method for the determination of 5 residual solvents in cyclophosphamide for injection.Methods HP-5 capillary column (30 m×0.53 mm,5 μm) was used and determined by flame ionization detector(FID).Dimethyfuran (DMF) was used as the solvent.Results The 5 residual 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. |
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| Keywords: | cyclophosphamide for injection gas chromatography (GC) residual solvents |
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