Determination of 7 Kinds of Organic Solvents Residualin Sugammadex Sodium Apis by Headspace Gas Chromatography
Objective:To establish a method for the determination of 7 kinds of organic solvents residual in Sugammadex So-dium raw material, including methanol, ethanol, acetone, acrylonitrile, methyl acrylate,benzene and ethyl acrylate. Meth-ods:The headspace gas chromatography was adopted. The samples were separated on a DB-624 capillary column(30 m× 0.32 mm,1.8 μm)using the temperature programming and a FID detector. The inlet temperature and the detector tempera-ture were set at 200℃ and 250℃,respectively. Nitrogen was used as the carrier gas with a flow rate of 3.0 mL/min. The spil-tratio was 10:1. The headspace equilibrium temperature was set at 60℃ and the equilibrium time was 30 min. Results:Ex-cellent chromatographic separation was achieved. There was a good linear relationship between the mass concentrations of the seven componentsand the peak are asin the corresponding concentration range(r=0.9981～0.9999). The average recov-eries were all between 91.6％ and 104.3％. Conclusion:The method is rapid, accurate, sensitive and can be used for the content determination of residual solvents in Sugammadex Sodium Apis.
Sugammadex Sodiumheadspace gas chromatographyresidual solventApis
万方数据
维普
