注射用美洛西林钠有关物质测定方法的改进  

Improvement of determination of related substances in Mezlocillin Sodium for Injection

作　　者：牛冲 窦艳丽 娄红祥[2] 徐玉文 NIU Chong;DOU Yanli;LOU Hongxiang;XU Yuwen(NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Shandong Research Center of Engineering and Technology for Consistency Evaluation of Generic Drugs,Shandong Institute for Food and Drug Control,Jinan 250101,China;Shandong University,Jinan 250014,China)

机构地区：[1]山东省食品药品检验研究院,国家药品监督管理局仿制药研究与评价重点实验室,山东省仿制药一致性评价工程技术研究中心,山东济南250101 [2]山东大学,山东济南250014

出　　处：《药学研究》2021年第4期229-231,261,共4页Journal of Pharmaceutical Research

基　　金：山东省重点研发计划(No.2017GSF20109)。

摘　　要：目的改进注射用美洛西林钠有关物质测定方法,提高杂质的检出率。方法采用C 18色谱柱(4.6 mm×250 mm,5μm),采用梯度洗脱,流速1.2 mL·min^(-1),检测波长为210 nm。结果在上述色谱条件下,美洛西林与相邻的杂质的分离度良好,定量限为9 ng,在30.07~240.56 ng范围内线性关系良好(r=0.9997)。杂质的个数及杂质总量较药典方法有明显提高。结论改进后的方法简单、快速,能更好地检出注射用美洛西林钠中的杂质。Objective To improve the method for determining related substances in Mezlocillin Sodium for Injection by HPLC.Methods The determination was performed on a C 18 column(4.6 mm×250 mm,5μm)at the flow rate 1.2 mL•min^(-1) with the wavelength at 210 nm.Gradient eluent was adapted.Results An excellent separation was achieved for mezlocillin and its neighbor impurities.The LOQ was 9 ng,The linearity were found in the range of 30.07~240.56 ng(r=0.9997).The impurities determined by this method were dramatically improved both in numbers and in contents than those measured by pharmacopeia method.Conclusion The improved method was simply and convenient,and it can determine the impurities well.

关 键 词：美洛西林 杂质 有关物质 高效液相色谱 

分 类 号：R927.2[医药卫生—药学]