中国执业药师Issue(7)：9-11,15,4.DOI:10.3969/j.issn.1672-5433.2015.07.002
气相色谱法测定比卡鲁胺中残留溶剂二甲基甲酰胺
Determination of Residual Solvent DMF in Bicalutamide by Gas Chromatography
阮昊 1陈悦1
作者信息
- 1. 浙江省食品药品检验研究院，浙江 杭州 310004
- 折叠
摘要
Abstract
Objective:To establish a method for the determination of residual solvent dimethylformamide (DMF)in the drug substance of bicalutamide by gas chromatography(GC).Methods:The residual solvent DMF in the drug substance was determined by GC equipped with FID detector and linked with Agilent INNOWAX capillary column(30.0 m×0.25 mm,0.25μm). The inlet temperature was at 200 ℃and the FID detector temperature was at 250 ℃. The column temperature rose by program, the initial temperature was at 60 ℃and raised to 200 ℃with a rate of 10 ℃/min and maintained for 3 min. The carrier gas was nitrogen and the flow rate of carrier gas was 1.0 mL/min. The injection volume was 1.0μL. The dissolved medium used was methylpyrrolidone(NMP). Results:The solvent DMF could be completely separated in chromatogram and there was a good linear relationship between the peak area and concentration of DMF within a certain range.Conclusion:The method is accurate and reliable with a good recovery. It can be applied in the determination of residual solvent DMF in the drug substance of bicalutamide.关键词
比卡鲁胺/残留溶剂/N,N-二甲基甲酰胺/气相色谱法Key words
Bicalutamide/Residual Solvents/DMF/Gas Chromatography引用本文复制引用
阮昊,陈悦..气相色谱法测定比卡鲁胺中残留溶剂二甲基甲酰胺[J].中国执业药师,2015,(7):9-11,15,4.
