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    毛细管气相色谱法测定兰索拉唑中有机溶剂残留量

    DETERMINATION OF RESIDUAL ORGANIC SOLVENTS IN LANSOPRAZOLE BY CAPILLARY GAS CHROMATOGRAPHY

    • 摘要: 以N,N-二甲基甲酰胺(DMF)为溶剂,丁酮为内标,采用OV-101毛细管色谱柱(30 m×0.22 mm),氢火焰离子化检测器,建立兰索拉唑中五种有机溶剂甲醇、乙醇、丙酮、二氯甲烷、乙酸乙酯残留量的定量分析方法.五种有机溶剂检出限分别为0.002 4%,0.002 4%,0.001 2%,0000 6%,0.000 6%;在10-1 000 mg·L-1浓度范围内,各组分线性关系良好;对应的平均回收率分别为100.8%±3.6%,102.1%±2.3%,99.97%±4.1%,99.63%±2.7%,102.3%±3.5%.

       

      Abstract: Residual organic solvents methanol,alcohol,acetone,dichloromethane, ethylacetate in Lansoprazole were determined by capillary gas chromatography using a OV-101 capillary column (0.22 mm×30 m).DMF was used as the solvent.Butanone was adopted as internal standard.Nitrogen gas was used as carrier.The front pressure of column was 56 kPa.The column temperature is programmed according to the following steps: it is held at 35 ℃ for 4 minutes then raised to 150 ℃ at a rate of 20 ℃ per minute,and it is retained for 10 minutes at 150 ℃.Methanol,alcohol,acetone,dichloromethane,ethylacetate were well separated in the column with the mean recovery of 100.8%±3.6%,102.1%±2.3%,99.97%±4.1%,99.63%±2.7%,102.3%±3.5% and their detection limits were determined as 0.002 4%,0.002 4%,0.001 2%,0.000 6%,0.000 6% respectively.The standard curves were linear in the concentration range of 10-1 000 μg·L-1 (r=0.999).

       

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