中国药业Issue(4)：43-44,45,3.
顶空气相色谱法测定双氯芬酸钠缓释胶囊中丙酮和乙醇残留量
Determination of Residual Amount of Acetone and Ethanol in Diclofenac Sodium Sustained-Release Capsules by HS-GC
王超众 1王萌萌 2姜佳 3杨敏 1任曼妮 1代昕阳1
作者信息
- 1. 黑龙江省齐齐哈尔市食品药品检验检测中心，黑龙江 齐齐哈尔 161006
- 2. 黑龙江省齐齐哈尔市第一医院，黑龙江 齐齐哈尔 161005
- 3. 黑龙江省齐齐哈尔市建华医院，黑龙江 齐齐哈尔 161006
- 折叠
摘要
Abstract
Objective To establish a headspace gas chromatography ( HS-GC ) method for determining the residual amountof acetone and ethanol in Diclofenac Sodium Sustained-Release Capsules. Methods The Agilent HP-FFAP capillary column(30 m × 0. 320 m,0. 25 μm) was used as the chromatographic column. The column temperature was 40 ℃. The injection port temperature was 180 ℃. The FID detector temperature was 240 ℃. The equilibrium temperature of the headspace gas bottle was 85 ℃. The equilibrium time was 30 minutes. The injection volume was 1 mL. The carrier gas was nitrogen. The flow rate was 2. 0 mL/min. Results The mass concentrations in the range of 0. 102 10-2. 042 00 g/L for acetone( r=0. 999 9) and in the range of 0. 102 51-2. 050 20 g/L for ethanol( r=1. 000 0) showed good linear relation with the peak area. The average recovery rates of acetone and ethanol were 99. 00% ( RSD=0. 98%,n=6) and 101. 54%( RSD=0. 48%,n=6). Conclusion The established method is simple,accurate and repeatable,which can be applied to deter-mine the residual amount of acetone and ethanol in Diclofenac Sodium Sustained-Release Capsules.关键词
顶空气相色谱法/双氯芬酸钠缓释胶囊/丙酮/乙醇/质量控制Key words
HS-GC/Diclofenac Sodium Sustained-Release Capsules/residual acetone/residual ethanol/quality control分类
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王超众,王萌萌,姜佳,杨敏,任曼妮,代昕阳..顶空气相色谱法测定双氯芬酸钠缓释胶囊中丙酮和乙醇残留量[J].中国药业,2015,(4):43-44,45,3.
