苯海拉明中残留溶剂测定方法研究  

Determination of Residual Solvents in Diphenhydramine

作　　者：黄莹[1] 饶春意[1] 

机构地区：[1]广东省药品检验所,广东广州510180

出　　处：《今日药学》2011年第12期734-735,755,共3页Pharmacy Today

基　　金：广东省药检系统课题(编号:ZA20101508)

摘　　要：目的建立原料药苯海拉明中残留溶剂甲苯,异丙醇限度检查的含量测定方法。方法采用顶空气相色谱法,火焰离子化检测器,以DMF为溶剂,色谱柱为DB-624毛细管柱(30 m×0.53 mm3,μm)。结果实验结果显示甲苯在0～270μg/ml(R=0.999 6)、异丙醇在0～700μg/ml(R=0.999 8)浓度范围内呈现良好线性关系。平均回收率分别为甲苯101.2%,RSD=4.59%(n=9);异丙醇:100.5%,RSD=3.9%(n=9)。结论方法简单、可靠、精确,可用于原料药苯海拉明中残留溶剂的含量控制。Objective To establish a GC method for the determination of residual solvents of toluene and isopropanol in the drug substance of Diphenhydramine.Methods Dimethylformamide was used as solvent,headspace gas chromatography was carried out with DB-624（30 m×0.53 mm,3 μm） capillary column and FID.Results The correlation coefficient of linearity was 0.999 6 for toluene within the concentration range of 0~270 μg/ml and 0.999 8 for isopropanol within the concentration range of 0~700 μg/ml.The average recoveries were 101.2% for toluene and 100.5% for isopropanol.Conclusion The method is simple,reliable and accurate.It can be applied in the quality control of drug substance of Diphenhydramine.

关 键 词：顶空气相色谱法 苯海拉明 甲苯 异丙醇 

分 类 号：R155.58[医药卫生—营养与食品卫生学]