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顶空气相色谱法测定枸橼酸喷托维林中有机溶剂残留量

Determination of Residual Organic Solvents in Pentoxyverine Citrate by Headspace Gas Chromatography
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摘要 目的建立测定枸橼酸喷托维林中有机溶剂残留量的顶空气相色谱法。方法采用FID检测器,色谱柱为HP-INNOWax毛细管柱(30m×0.53mm,1.0μm),进样口温度180℃,柱温90℃,检测器温度250℃。结果在该试验条件下,乙醇和环氧乙烷质量浓度与峰面积线性关系良好,并可同时测定。结论顶空气相色谱法简单、准确、灵敏度高、重复性好,可用于该药物中有机溶剂残留量的测定。 Objective To establish a headspace GC method for the determination of the residual organic solvents in pentoxyverine citrate. Methods The residual organic solvents were quantitatively determined by headspace GC with the FID detector. The capillary column was HP -INNOWax (30 m × 0.53 mm, 1.0 μm). The injector temperature was 180 ℃, the column temperature was 90 ℃, and the detector temperature was 250 ℃. Results Under this experimental condition, there was the good linear relationship between the experimental concentrations of ethanol and oxacyclopropane with the peak area. Furthermore, the simultaneous determination was obtained. Conclusion The method is simple, accurate, sensitive and reproducible, which can be used for the determination of the residual organic solvents in pentoxyverine citrate.
出处 《中国药业》 CAS 2010年第13期44-45,共2页 China Pharmaceuticals
关键词 枸橼酸喷托维林 顶空气相色谱法 有机溶剂残留量 pentoxyverine citrate headspace GC residual organic solvents
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参考文献1

  • 1周海钧(主译).药品注册的国际技术要求质量部分[M].北京:人民卫生出版社,2001:343.

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