HPLC-IC法测定普罗碘铵的有关物质  

Determination of Prolonium Iodide by HPLC-IC

作　　者：毛志英 徐兰兰 韦娴 MAO Zhi-ying;XU Lan-lan;WEI Xian(Jiangsu Wuzhong Pharmaceutical Group Corporation,Nanjing 210009,China;Nanjing Jiutian Bio-medical Technology Co.Ltd.,Nanjing 210009,China)

机构地区：[1]江苏吴中医药集团有限公司药物研发分公司,江苏南京210009 [2]南京九天生物医疗科技有限公司,江苏南京211800

出　　处：《海峡药学》2023年第11期36-40,共5页Strait Pharmaceutical Journal

摘　　要：目的建立了HPLC-IC法测定普罗碘铵有关物质的方法。方法以甲烷磺酸溶液为淋洗液,采用梯度洗脱,用阳离子交换色谱柱(Dionex IonPac^(TM) CS 174×250 mm),电导检测器检测,抑制电流88 mA。结果建立的方法系统适用性、专属性、精密度和准确度均符合要求,各杂质在限度25%~120%范围内线性关系良好。结论该测定方法操作简便、准确,可用于普罗碘铵有关物质的测定。OBJECTIVE A method for the determination of Prolonium Iodide by HPLC-IC was established.METHODS The eluent was a methanesulfonic acid solution.The method adopted gradient elution,and used a cation exchange chromatographic column(Dionex IonPac^(TM) CS 174×250 mm),and detected with a conductivity detector with an inhibition current of 88 mA.RESULTS The results showed that the system applicability,specificity,precision and accuracy of the method met the requirements,and each impurity had a good linear relationship within the limit of 25%to 120%.CONCLUSION The method was simple and accurate,and can be used for the determination of related substances of prodronium iodide.

关 键 词：普罗碘铵 离子色谱法 有关物质 

分 类 号：R927[医药卫生—药学]