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。
GC-FID-derivative technique determination of hydrazine hydrate in afatinib maleate
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.
万方数据
维普
