医药导报Issue(2):185-188,4.DOI:10.3870/j.issn.1004-0781.2016.02.021
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
Determination of Aniline,2-Aminophenol and 4-Aminophenol in Mesalazine Sustained Release Granules by Gas Chromatography
张雪玲 1于晓秋 1张玥 2崔雪丹 3王超众4
作者信息
- 1. 齐齐哈尔医学院附属第二医院药剂科,齐齐哈尔 161006
- 2. 黑龙江省齐齐哈尔市第一医院呼吸科,齐齐哈尔161005
- 3. 黑龙江省齐齐哈尔市第一医院护理部,齐齐哈尔 161005
- 4. 黑龙江省齐齐哈尔市食品药品检验检测中心,齐齐哈尔 161006
- 折叠
摘要
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.关键词
美沙拉嗪缓释颗粒/色谱法,气相/苯胺/2-氨基苯酚/4-氨基苯酚/有关物质/质量控制Key words
Mesalazine sustained release granules/Chramatograph, gas/Aniline/2-aminophenol/4-aminophenol/Related substances/Quality control分类
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张雪玲,于晓秋,张玥,崔雪丹,王超众..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[J].医药导报,2016,(2):185-188,4.