泮托拉唑钠杂质校正因子测定  

Determination of Impurities in Pantoprazole Sodium

作　　者：任春[1] 武洋[1] 张迪[1] 孙苓苓[1] 刘海淼[1] 

机构地区：[1]辽宁省食品药品检验所,辽宁沈阳110023

出　　处：《解放军药学学报》2012年第4期323-324,330,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的采用HPLC法测定泮托拉唑钠中的有关物质。方法采用C18色谱柱,以0.01 mol·L-1磷酸氢二钾溶液为流动相A(用磷酸调节pH值至7.0);乙腈为流动相B梯度洗脱,检测波长289 nm。结果杂质C相对于主成分泮托拉唑钠的相对保留时间约为0.7,校正因子为0.6,检测限为0.2 ng。结论本方法准确、简便、快速,适用于泮托拉唑钠中杂质的控制。Objective To modify the method for determination of the related substances in pantoprazole sodium.Methods The analytical column was C18 column.0.01 mol · L-1K2HPO4 solution（adjusting pH to 7.0 with phosphoric acid）-acetonitrile was applied as mobile phase.The detective wavelength was 289 nm.Results The relative retention time of impurity C was about 0.7 with the correction factor of 0.6,the detection limit was 0.2 ng.Conclusion The method is accurate,simple,sensitive and suitable for quality control of impurities in Pantoprazole Sodium.

关 键 词：泮托拉唑钠 有关物质 校正因子 HPLC 

分 类 号：R927.1[医药卫生—药学]