摘要
Abstract
Objective To establish a method of determining 4 kinds of residual organic solvents(methanol,ethanol,acetonitrile, dichloromethane) in tamsulosin hydrochloride raw medicine. Methods Capillary gas chromatography was adopted,the column was DB-FFAP capillary gas chromatography column(30 m × 0. 53 mm,3. 0 μm),the carrier gas was nitrogen with hydrogen flame ionization de-tector. The temperature was programmed to be 40 ℃ for 6 min,and then programmed to be 200 ℃ at 30 ℃ /min to maintain for 5 min. The inlet temperature was 200 ℃,the detector temperature was 250 ℃,and the split ratio was 20:1. Results The 4 kinds of organic solvents were separated completely,The mass concentrations of methanol,ethanol,acetonitrile and dichloromethane were linear in the range of 13. 50 -270. 00 ,11. 56 -231. 20 ,9. 57 -191. 32 ,1. 36 -27. 20 μg / mL . The results of recovery test were good . Conclusion The sensitivity and accuracy of the method can meet the requirement of organic solvent residue. It is suitable for the de-termination of residual organic solvents in tamsulosin hydrochloride raw medicine.关键词
盐酸坦洛新/原料药/有机溶剂/残留量/气相色谱法Key words
tamsulosin hydrochloride/pharmaceutical raw materials/organic solvent/residual quantity/gas chromatography分类
医药卫生
