毛细管气相色谱法测定西沙必利中有机溶剂残留量

GC determination of residual organic solvents in cisapride

目的:建立测定西沙必利中有机溶剂残留量的方法。方法:采用毛细管气相色谱法测定,色谱柱为 DB-624毛细管柱;程序升温,初始温度为40℃,维持6 min 后,以10℃·min^(-1)升温至200℃保持5 min。结果:在确定的色谱条件下各组分能基线分离,线性关系良好;加样回收率为91.3%～103.5%。最低检测浓度为0.45～6μg·mL^(-1)。结论:该方法灵敏度和准确度均达到有机溶剂残留量枪测的要求,可用于西沙必利中有机溶剂残留量的测定。

Objective：To establish a method for the determination of residual organic solvents in cisapride. Method： Headspace gas chromatography was adopted using a DB -624 capillary column （30 m × 0. 53 mm × 3 μm） ,The initial column temperature was 40 ℃ maintained for 6 min and then raised（ 10 ℃ · min ^-1 ）to 200 ℃ for 5 min. Results：Under the chromatographic condition, all solvents were separated and had good linear range ;the average recoveries were 91.3% - 103.5%. Conclusion：The method is sensitive and accurate. It can be used to determine the residual organic solvents in cisapride.