桂利嗪片及其原辅料中七种残留溶剂测定  

Determination of Seven Residual Solvents in Cinnarizine Tablets and Its Raw Materials and Excipients

作　　者：王鹏 刘慧 汪湘君 刘贞 钟振华 WANG Peng;LIU Hui;WANG Xiangjun;LIU Zhen;ZHONG Zhenhua(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China)

机构地区：[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《药品评价》2024年第4期421-424,共4页Drug Evaluation

摘　　要：目的建立用于测定桂利嗪片及其原辅料中乙醇、丙酮、异丙醇、正己烷、三乙胺、正庚烷、甲苯七种残留溶剂的测定方法。方法色谱柱为DB-624毛细管色谱柱(60 m×0.32 mm×1.80μm),采用溶液直接进样程序升温法,载气为氮气,FID检测器;对收集到的148批次桂利嗪片,14批次桂利嗪原料及10批次辅料进行七种有机溶剂残留量测定。结果七种有机溶剂能有效分离,在相应的浓度范围内线性关系良好,线性相关系数分别为0.9983、0.9985、0.9984、0.9989、0.9994、0.9994、0.9986,平均回收率分别为95.8%、96.4%、98.5%、94.4%、97.4%、96.2%、99.1%。结论本方法灵敏、准确、重现性好,可用于制剂及其原辅料中残留溶剂的检测。Objective To establish a method for determination of residual solvents including ethanol,acetone,isopropanol,n-hexane,triethylamine,n-heptane and tolnene in cinnarizine tablets and cinnarizine raw materials and excipients.Methods Chromatographic column was DB-624(60 m×0.32 mm×1.80μm),with FID detector,the direct injection,temperature programmed,with nitrogen as carrier;the residues of seven organic solvents in 148 batches of cinnarizine tablets,14 batches of cinnarizine raw materials and 10 batches of excipients were determined.Results Seven residual organic solvents well separated efficiently by GC,with good linearity within the observed concentration range,and the correlation coefficient were are 0.9983,0.9985,0.9984,0.9989,0.9994,0.9994 and 0.9986 respectively,the average recoveries were 95.8%,96.4%,98.5%,94.4%,97.4%,96.2%and 99.1%respectively.Conclusion The method is sensitive and accurate with good stability,which can be used to detection of residual solvents preparations and apis.This method is sensitive,accurate and reproducible,and can be used for the detection of residual solvents in preparations,raw materials and excipients.

关 键 词：桂利嗪 残留溶剂 气相色谱法 

分 类 号：R927.1[医药卫生—药学]