摘要
目的建立气相色谱法分别测定替米沙坦中残留有机溶剂甲醇、乙醇、丙酮、二氯甲烷、氯仿、乙二醇和二甲基甲酰胺。方法以DB-624弹性石英毛细管柱为色谱柱(30m×0.53mm),载气为氮气,采用氢火焰离子化检测器,进样口温度为200℃,检测器温度为250℃。顶空进样法采用程序升温(50℃,保持15min,以30℃.min-1升至160℃,保持5min),进样量1.0mL。直接进样法柱温为100℃,进样量1.0μL。结果3批样品中7种有机溶剂残留量均符合规定。结论本方法可测定替米沙坦中的有机溶剂残留量,方法简单准确。
OBJECTIVE To determine the contents of residual organic solvents： methanol, ethanol, acetone, dichloromethane, chloroform, ethyleneglycol, dimethylformamide in telmisartan by GC. METHODS DB-624 column was used. The carrier gas was nitrogen. The injection port and detector tempertures were 200℃ and 250℃ respectively. Headspace injection method intial temperature was kept at 50℃ for 15min, then the temperature was raised to 160℃ at the rate of 30℃· min^-1, and subsequently sustained for 5 min. Straightforward injection method temperature was kept at 100℃ RESULTS The contents of seven residual volatile organic solvents in three batches of samples were complied with the specification requirements. CONCLUSION The method is simple, rapid and precision.
出处
《海峡药学》
2008年第12期5-7,共3页
Strait Pharmaceutical Journal
关键词
气相色谱法
残留量
替米沙坦
GC（ Capillary gas chromatography）
Residual solvents
Telmisartan
