顶空气相色谱法测定奥利司他中残留溶剂
Determination of residual organic solvents in orlistat by headspace gas chromatography
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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。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.
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Key words:
- headspace gas chromatography /
- orlistat /
- residual organic solvents
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