气相色谱法测定沙格列汀中残留溶剂

Determination of Residual Organic Solvents in Saxagliptin by Gas Chromatography

目的:建立气相色谱法测定沙格列汀中5种残留溶剂的方法。方法:采用Agilent DB-624毛细管柱,检测器为氢火焰离子化检测器,检测器温度250℃,采用程序升温,测定沙格列汀中残留的甲醇、乙腈、异丙醇、二氯甲烷和乙酸乙酯。结果:5种残留溶剂均完全分离,在所考察的浓度范围内线性关系良好,平均回收率在99.87%~105.64%之间。结论该方法可用于检测沙格列汀中的残留溶剂。

Objective:To establish a method for the determination of five residual organic solvents in Saxagliptin by Gas Chromatography.Method:The Agilent DB-624 capillary column was adopted,the temperature programming and FID detector was used,the detector temperature was 250℃.Make an quantitative analysis of the residual solvent in Saxagliptin including Methanol,Acetonitrile,Isopropanol,Dichloromethane and Ethyl acetate.Results:The five residual solvents were completely separated,and the calibration curves of each solvent had good linear relationship,the average recovery was in the range of 99.87%~105.64%.Conclusion It can be applied in detection of residual solvents in Saxagliptin.