顶空毛细管GC法测定佐匹克隆原料药中有机溶剂的残留量  

Determination of Residual Organic Solvents in Zopiclone API by Headspace Capillary GC

作　　者：兰为环 张绿茵 李爽 唐海 Lan Weihuan;Zhang Lvyin;Li Shuang;Tang Hai(Jiangsu Tasly Diyi Pharmaceutical Co.,Ltd,Tianjin 300400)

机构地区：[1]江苏天士力帝益药业有限公司,天津300400

出　　处：《化工与医药工程》2022年第1期25-29,共5页Chemical and Pharmaceutical Engineering

摘　　要：建立测定佐匹克隆原料药中3种有机溶剂(三氯甲烷、苯、二甲苯)残留量的方法,采用顶空毛细管气相色谱法(GC)进行检测,并对该方法进行系统的方法学验证,结果显示三氯甲烷、苯及二甲苯3种有机溶剂均完全分离,专属性良好;三氯甲烷、苯、二甲苯平均回收率分别为100.0%,99.0%,96.8%,定量限分别为1.78μg/mL、0.0645μg/mL、0.390μg/mL。该测定方法操作简单,灵敏度高,准确性好,可为佐匹克隆中有机溶剂残留量的控制提供依据。A method was established to determine the residues of three organic solvents(chloroform,benzene and xylene)in zopiclone API.Headspace capillary gas chromatography(GC)was used for detection,and the method was systematically verified.The results showed that chloroform,benzene and xylene were completely separated and had good specificity;The average recoveries of chloroform,benzene,xylene were 100.0%,99.0%,96.8%respectively.The limit of quantification(LOQ)were 1.78μg/mL,0.0645μg/mL and 0.390μg/mL,respectively.The method had the advantages of simple operation,high sensitivity and accurate,which could be applied to the quality control of residues in Zopiclone.

关 键 词：气相色谱 顶空进样 佐匹克隆 残留溶剂 三氯甲烷 苯 二甲苯 

分 类 号：R927[医药卫生—药学]