气相色谱法测定奥氮平原料药中6种残留溶剂含量

Determination of Six Organic Solvent Residues in Olanzapine by GC

目的:建立奥氮平原料中6种有机溶剂残留量的测定方法。方法:采用气相色谱法,色谱分离条件是色谱柱(5%-苯基)-甲基聚硅氧烷的毛细管柱(DB-5 30 m×0.53 mm×1.0 um);程序升温,40℃维持4 min,以每分钟20℃升温至120℃并保持2 min;检测器FID,温度255℃;进样口温度160℃。结果:建立的色谱方法在所考察的浓度范围内,线性关系良好,各溶剂回收率符合要求。结论:本法灵敏、准确,适用于奥氮平原料药中6种有机残留量的检测。

Objective： To establish a method for the determination of six organic solvent residue in Olanzpine,Methods： Gas chromatography was applied.Chromatographic conditions were： capillary column（DB-5,30 m×0.53 mm×1.0 um）;temperature programming started at 40 ℃,holding for 4 min,then increased to 120 ℃ at a rate of 20 ℃/min,holding for 2 min;the temperature of flame ionization detector（FID） was 255 ℃;the injector temperature was 160 ℃.Results： A good linear relationship was found within the studied range and the reovery could meet the requirment.Conclusion： The established method is sensitive,accurate,and suitable for the determination of the organic solvent residue in Olanzpine.