Determination of Aniline,2-Aminophenol and 4-Aminophenol in Mesalazine Sustained Release Granules by Gas Chromatography
10.3870/j.issn.1004-0781.2016.02.021
- VernacularTitle:气相色谱法测定美沙拉嗪缓释颗粒中苯胺和2-氨基苯酚及4-氨基苯酚的含量
- Author:
Xueling ZHANG
;
Xiaoqiu YU
;
Yue ZHANG
;
Xuedan CUI
;
Chaozhong WANG
- Publication Type:Journal Article
- Keywords:
Mesalazine sustained release granules;
Chramatograph,gas;
Aniline;
2-aminophenol;
4-aminophenol;
Related substances;
Quality control
- From:
Herald of Medicine
2016;(2):185-188
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a gas chromatography ( GC) method for determination of aniline,2-aminophenol and 4-aminophenol in mesalamine sustained release granules. Methods An HP-5 (10 m×0.53 mm,2.65 μm) capillary GC column was adopted. The carrier gas was high purity nitrogen at a flow rate of 15 mL.min-1 . The inlet temperature was controlled at 280 ℃ and the FID detector temperature was 300℃. The oven temperature was initially held at 70℃ for 2 min and was then programmed to 150 ℃ at 10℃.min-1 and held for 6 min. Results A good resolution was obtained between the peaks of the 3 impurities at chromatographic conditions above. The recoveries of aniline, 2-aminophenol and 4-aminophenol were among 98.04% to 103.00%. The precision and linearity equations were good. Conclusion The method can be adopted for the quality control of mesalazine sustained release granules.