顶空毛细管气相色谱法测定碘佛醇原料药中的残留溶剂  

Determination of Residual Solvents in Ioversol Raw Material Drug by Headspace Capillary Gas Chromatography

作　　者：李超 张勉 唐华 

机构地区：[1]重庆市食品药品检验所,重庆401121

出　　处：《中国药业》2013年第4期37-38,共2页China Pharmaceuticals

摘　　要：目的建立测定碘佛醇原料药中甲醇、正丁醇的残留量顶空毛细管气相色谱法。方法以ZB-Wax毛细管柱(30 m×0.32 mm,0.25μm)为色谱柱,水为溶剂,正丙醇为内标,采用顶空进样法测定碘佛醇原料药中甲醇、正丁醇的残留量。结果甲醇、正丁醇质量浓度分别在122.2～366.6μg/mL(r=0.998 3)和128.4～385.2μg/mL(r=0.999 3)范围内呈良好的线性关系,平均加样回收率分别为102.86%(n=9,RSD=1.43%)和96.68%(n=9,RSD=2.69%),最低检出质量浓度分别为0.66μg/mL和0.04μg/mL。结论该方法简便灵敏,结果准确可靠,能较好地检测碘佛醇原料药中有机溶剂残留量,控制产品质量。Objective To establish the headspace capillary gas chromatographic method for the content determination of residual solvents such as methanol and n-butanol in ioversol raw material drug.Methods Methanol and n-butanol in ioversol raw material drug were determined by the headspace gas chromatography with the ZB-WAX capillary column（30 m×0.32 mm,0.25 μm）.Results Methanol and n-butanol showed the linear relation within the concentrations of 122.2-366.6 μg/mL（r=0.998 3） and 128.4-385.2 μg/mL（r=0.999 3）,respectively.The mean recovery rates were 102.86%（n=9,RSD=1.43%）and 96.68%（n=9,RSD=2.69%）,respec-tively.The detection limits were 0.66 μg/mL and 0.04 μg/mL.Conclusions This established method is simple,sensitive,accurate and reliable for the content determination of residual solvents in ioversol raw material drug and the quality control of this product.

关 键 词：碘佛醇 残留溶剂 毛细管气相色谱 顶空进样 

分 类 号：R927.12[医药卫生—药学]