| 顶空气相色谱法测定奥利司他中残留溶剂 |
| 投稿时间：2010-04-02 修订日期：2010-04-27 点此下载全文 |
| 引用本文：温燕,闻俊,陶霞.顶空气相色谱法测定奥利司他中残留溶剂[J].药学实践杂志,2010,28(3):201~202 |
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| 中文摘要:目的:建立奥利司他原料药中有机溶剂残留量的测定方法。方法:采用顶空进样毛细管气相色谱法,HP-IN-NOWAX毛细管柱（30 mm×0.32 mm,0.25μm）,以氮气为载气,用FID检测器,测定奥利司他原料药中正己烷、正庚烷、甲醇和乙腈的残留量。结果: 4种有机溶剂完全分离,浓度在考察范围内与峰面积具有良好的线性关系,r为0.999 0-0.999 3,平均回收率为97.1%-101.9%,精密度RSD均小于10%,最低检出限为0.009-1.833μg/ml。结论:本法快速、灵敏、准确,可用于本品中4种有机溶剂残留量的测定。 |
| 中文关键词:顶空气相色谱法 奥利司他 有机溶剂残留量 |
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| Determination of residual organic solvents in orlistat by headspace gas chromatography |
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| Abstract:Objective To establish a method for determination of four residual organic solvents in orlistat.Methods The residual organic solvents in orlistat are hexane、heptane、methanol and acetonitril.They were quantitatively determined by headspace gas chromatography(GC) on HP-INNOWAX column with FID detector,nitrogen as the carries.Results Four residual solvents were completely separated.There was a good linearity in the experimental concentration(r=0.999 0～0.999 3).The RSD of precision was less than 10%.The average recovery rate ranged from 97.1% to 101.9%.The detection limits was between 0.009～1.833 μg/ml.Conclusion The method proves to be rapid,sensitive and accurate.It can be used for quality control for the determination of four residual organic solvents in orlistat. |
| keywords:headspace gas chromatography orlistat residual organic solvents |
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