GC法测定替硝唑注射液中四种杂质的含量  

Study on the Determination of Four Impurities Residues in Tinidazole Injection by GC

作　　者：刘毅 左瑞雅 孙花丽 Liu Yi;Zuo Ruiya;Sun Huali(Xi'an WanLong Pharmaceutical Co.,Ltd.,Xi'an,Shaanxi 710119,China;Xi'an Manareco New Material Co.,Ltd.,Xi'an,Shaanxi 710077,China;Shaanxi JunjingMed Biomedical Technology Co.,Ltd.,Xi'an,Shaanxi 712100,China)

机构地区：[1]西安万隆制药股份有限公司,陕西西安710119 [2]西安瑞联新材料股份有限公司,陕西西安710077 [3]陕西君境迈德生物医药科技有限公司,陕西西安712100

出　　处：《化工与医药工程》2024年第6期27-33,共7页Chemical and Pharmaceutical Engineering

摘　　要：建立了同时测定替硝唑注射液中四种杂质含量的气相色谱法。采用聚乙二醇(PEG-20M)为固定液的毛细管色谱柱,FID检测器,进样口220℃,检测器240℃,柱温为220℃,分流比为5∶1,采集色谱图,以外标法进行计算,测试结果表明:环氧丙烷在2.581~7.557μg/mL、一缩二乙二醇在2.364~7.465μg/mL、一缩二丙二醇在1.300~747.239μg/mL、二缩三丙二醇在10.272~149.992μg/mL范围内线性关系良好。环氧丙烷加标平均回收率为99.2%,RSD为0.46%;一缩二乙二醇加标平均回收率为99.0%,RSD为0.54%;一缩二丙二醇加标平均回收率为99.1%,RSD为0.46%;二缩三丙二醇加标平均回收率为99.0%,RSD为0.43%。该检测方法操作简便、准确可靠、稳定性好,适用于替硝唑注射液中四种杂质含量测定。A gas chromatography method was developed for the simultaneous determination of four impurities in Tinidazole injection.Capillary chromatography column with PEG(PEG-20M)as fixed liquid,FID detector,inlet 220℃,detector 240℃,column temperature 220℃,shitter ratio 5∶1,chromatogram was collected and calculated by external standard method.The test results showed that:The linear range of propylene oxide was 2.581-7.557μg/mL,diethylene glycol was 2.364-7.465μg/mL,dipropylene glycol was 1.300-747.239μg/mL,and tripropylene glycol was 10.272-149.992μg/mL.The average recovery of propylene oxide was 99.2%and RSD was 0.46%.The average recovery of diethylene glycol was 99.0%and RSD was 0.54%.The average recovery of dipropylene glycol was 99.1%and RSD was 0.46%.The average recovery of triepropanediol was 99.0%and RSD was 0.43%.The method is simple,accurate,reliable and stable,and is suitable for the determination of four impurities in tinidazole injection.

关 键 词：气相色谱法 替硝唑注射液 环氧丙烷 杂质含量 

分 类 号：TQ460[化学工程—制药化工]