GC-FID-derivative technique determination of hydrazine hydrate in afatinib maleate
10.19778/j.chp.2024.03.013
- VernacularTitle:衍生气相色谱法测定马来酸阿法替尼中水合肼
- Author:
Ningning JIA
1
;
Yingya CAO
;
Na ZHENG
;
Youyou TANG
Author Information
1. 南京华威医药科技集团有限公司,南京 210000
- Keywords:
afatinib maleate;
derivatization;
GC;
hydrazine hydrate
- From:
Drug Standards of China
2024;25(3):296-298
- CountryChina
- Language:Chinese
-
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.
