气相色谱-质谱联用法用于注射用泮托拉唑钠药用胶塞中可浸出物的测定  

Determine the content of extractable extract in pharmaceutical stopper of pantoprazole sodium for injection by GCMS method

作　　者：杨乾展 邱妍川[2] YANG Qianzhan;QIU Yanchuan(Shimadzu Enterprise Management(China)Co.,Ltd.,Chongqing Branch,Chongqing,400010,China;Chongqing Medical and Pharmaceutical College,Chongqing,401331,China)

机构地区：[1]岛津企业管理(中国)有限公司重庆分公司,重庆400010 [2]重庆医药高等专科学校,重庆401331

出　　处：《环境化学》2024年第11期3935-3938,共4页Environmental Chemistry

摘　　要：建立了一种使用气相色谱-质谱联用仪测定注射用泮托拉唑钠药用胶塞中可浸出物定性、定量的方法.对泮托拉唑钠药用胶塞浸出液采用全扫描模式进行定性分析,对浸出物抗氧剂264和油酸酰胺采用选择离子模式建立了定量分析方法.经方法学验证,抗氧剂264浓度在0.1—100 g·mL^(−1),油酸酰胺浓度在1—100 g·mL^(−1)范围内,均具有较好的线性关系,线性相关系数均大于0.999.取1g·L^(−1)和5 g·L^(−1)两种浓度的对照品溶液重复进样5次,两个化合物保留时间和峰面积的相对标准偏差均小于0.04%和6%.重复性良好.取加速稳定性样品进行检测并进行加标回收实验,加标回收率在93.5%—103.6%之间.该方法操作简单,结果准确稳定,可用于注射用泮托拉唑钠药用胶塞中两种浸出物的定量检测.A method for the qualitative and quantitative determination of extractable substances in Pantoprazole sodium for injection was established by gas chromatography-mass spectrometry.The extraction solution of Pantoprazole sodium was qualitatively analyzed by SCAN,and the extract antioxidant 264 and oleic acid amide were quantitatively analyzed by SIM.The results showed that the concentration of antioxidant 264 was 0.1—100µg·mL^(−1),and the concentration of oleamide was 1—100µg·mL^(−1),and the linear correlation coefficient was greater than 0.999.The reference solution of 1µg·L^(-1)and 5µg·L^(-1) were repeated for 5 times,and the relative standard deviations of the retention time and peak area of the two compounds were less than 0.04%and 6%.Good repeatability.The accelerated stability samples were tested and the recovery rate was between 93.5%and 103.6%.The method is simple to operate,accurate and stable,and can be used for the quantitative determination of two extracts in Pantoprazole sodium for injection.

关 键 词：气相色谱质谱联用仪 药用胶塞 泮托拉唑 可浸出物 

分 类 号：X-1[环境科学与工程] O6[理学—化学]