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.
作者
牛冲
窦艳丽
娄红祥
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)
出处
《药学研究》
CAS
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)。
