曲司氯铵中有机溶剂残留的顶空毛细管气相色谱法测定  

Determination of Residual Organic Solvents in Trospium Chloride by Headspace Capillary Gas Chromatography

作　　者：杨新颖[1] 宋伟国 侯准[1] 桑立红[1] 方浩[1] 

机构地区：[1]山东大学药学院,山东济南250012 [2]寿光富康制药有限公司,山东寿光262700

出　　处：《中国医药工业杂志》2014年第2期164-166,共3页Chinese Journal of Pharmaceuticals

摘　　要：建立了顶空毛细管气相色谱法测定曲司氯铵中可能残留的乙醚、内酮、甲醇、二氯甲烷、乙醇、三氯甲烷和二甲基甲酰胺。以二甲亚砜为溶剂，采用AC20毛细管柱和氢火焰离子化检测器。上述7种有机溶剂分别在50～1000、50～1000、30～600、6～120、50～1000、0．6～12和88～176μg／ml浓度范围内线性关系良好，回收率分别为98．1％、100．9％、97．5％、99．2％、98．6％、95．2％和94．2％，RSD不大于3．4％。A static headspace capillary gas chromatography method was established for the determination of seven residual solvents, such as ether, acetone, methanol, dichloromethane, ethanol, chloroform and DMF, in trospium chloride. An AC20 capillary column and flame ionization detector were used with DMSO as the solvent. Their calibration curves were linear in the concentration ranges of 50 - 1 000, 50 - 1 000, 30 - 600, 6 - 120, 50 - 1 000, 0.6 - 12 and 8.8 - 176 μg/ml, respectively. Their recoveries were 98.1%, 100.9%, 97.5 %, 99.2%, 98.6%, 95.2% and 94.2%, with RSDs no more than 3.4 %.

关 键 词：曲司氯铵 有机溶剂残留 顶空毛细管气相色谱 测定 

分 类 号：TQ460.72[医药卫生—药物分析学] O657.71[化学工程—制药化工]