毛细管气相色谱法测定右旋兰索拉唑中溶剂残留量  

Determination of the solvent residue in dexlansoprazole by capillary gas chromatography

作　　者：李松荷 徐艳 王东凯[1] 赵云丽[1] 陈明明[2] 于治国[1] LI Songhe;XU Yan;WANG Dongkai;ZHAO Yunli;CHEN Mingming;YU Zhiguo(School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China;Institute for Drug and Instrument Control of Shenyang Military Area Comrnand,Shenyang 110026, China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]沈阳军区药品仪器检验所,辽宁沈阳110026

出　　处：《沈阳药科大学学报》2018年第5期399-402,408,共5页Journal of Shenyang Pharmaceutical University

摘　　要：目的建立直接进样毛细管气相色谱法测定右旋兰索拉唑中5种有机溶剂残留量。方法采用HP-WAX(30 m×0.32 mm×0.5μm)色谱柱,氮气作为载气,氢火焰离子化检测器,采用N,N-二甲基甲酰胺作为溶剂,以乙腈作为内标物,检测右旋兰索拉唑原料药中残留溶剂。结果甲苯、甲基叔丁基醚、乙酸乙酯、丙酮、正庚烷线性关系良好(r=0.999 7~0.999 8),平均回收率为98.6%~100.4%,定量限分别为0.80、1.21、2.46、1.86和0.81 mg·L-1。结论所建立的检测方法适用于对右旋兰索拉唑中5种残留溶剂的同时测定。Objective To establish a capillary gas chromatography method for the determination of five kinds of residual solvents in dexlansoprazole. Methods The samples were separated on an HP-WAX capillary column（ 30 m × 0. 32 mm × 0. 5 μm） with the FID detector. Nitrogen was used as a carrier gas and acetonitrile was used as the internal standard. Results There were good linear relationships in the experimental concentrations of methyl tert-butylethe,N-heptane,acetone,ethyl acetate and methylbenzene（ r = 0. 999 7-0. 999 8）. The average recoveries ranged from 98. 6% to 100. 4%. The limits of quantification were separately 0. 80,1. 21,2. 46,1. 86 and 0. 81 mg·L-1. Conclusion The method is simple,sensitive,and accurate with good durability. It can be used for the determination of five residual organic solvents in dexlansoprazole.

关 键 词：右旋兰索拉唑 溶剂残留 毛细管气相色谱法 内标法 

分 类 号：R917[医药卫生—药物分析学]