GC-FID-derivative technique determination of hydrazine hydrate in afatinib maleate
贾宁宁 1曹迎亚 1郑娜 1唐由由1
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作者信息
1. 南京华威医药科技集团有限公司,南京 210000
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摘要
目的:建立衍生气相色谱法检测马来酸阿法替尼中的水合肼.方法:采用丙酮-冰醋酸衍生,利用DB-225毛细管柱(0.25 mm × 30 m × 0.25 μm)分离,氢火焰离子化(FID)检测器.结果:方法在1.258～50.34μg·mL-1具有良好的线性(r＞0.999),检测限为0.001％,回收率91.7％～107.2％.结论:该方法检测成本低廉,方法简便,结果可靠,重现性好,可用于马来酸阿法替尼中水合肼衍生检测分析.
Abstract
Objective:To establish a derivative gas chromatography method for quantitative determination of hydra-zine hydrate in afatinib maleate.Methods:Acetone-glacial acetic acid solution and DB-225 capillary column(0.25 mm×30 m × 0.25 μm)and FID was used to separate andquantitative decermine hydrazine hydrate.Results:Excellent linearity showed within the range of 1.258-50.34 µg·mL-1(r＞0.999),detection limit was 0.001％,and the recovery rate was 91.7％-107.2％.Conclusion:The method shows low testing cost,satisfac-tory repeatability,simplicity and convenience,and is valid in derivative separation and analysis of hydrazine hydrate in afatinib maleate.
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