中国药业2016，Vol.25Issue(3)：47-48,49,3.
气相色谱法测定齐拉西酮冻干粉针剂中叔丁醇残留量
Invenstigation of Tert-butyl Alcohol Residue in Ziprasidone Freeze-Dried Powder Injection by Gas Chromatography
张李巧 1李子君2
作者信息
- 1. 四川省成都市妇女儿童中心医院，四川 成都 610091
- 2. 湖南省岳阳市食品药品检验所，湖南 岳阳 414000
- 折叠
摘要
Abstract
Objective To establish the gas chromatography method to determine the tert-butyl alcohol residue in Ziprasidone Freeze-Dried Powder Injection. Methods PEG-20M capillary column ( 30 m × 0. 32 mm, 0. 50 μm ) was used with external standard measure-ment. The detection limits, standard curve, recovery rate and stability of the reference substance of Tert-butyl alcohol was detected by gas chromatography, and the residue of Tert-butyl in different batches of Ziprasidone freeze-dried powder injection was investigated. Results The mass concentration of tert-butyl alcohol in the range of 20-400 μg/mL had good linear relationship with the peak area ( r=0. 999 3 ) , the detection limit was 0. 010 μg/mL, the recovery was 97. 15%, 101. 54%, 101. 86 %, and the precision and re-covery RSD ﹤ 1. 5%. Conclusion This method is sensitive with good reproducibility and good system suitability, and is suitable for the determination of the tert-butyl alcohol residue in Ziprasidone Freeze-Dried Powder Injection.关键词
叔丁醇/齐拉西酮/气相色谱法/残留量Key words
tert-butyl alcohol/ziprasidone/gas chromatography/residue分类
医药卫生引用本文复制引用
张李巧,李子君..气相色谱法测定齐拉西酮冻干粉针剂中叔丁醇残留量[J].中国药业,2016,25(3):47-48,49,3.
