HPLC法测定注射用盐酸头孢吡肟中的AE-活性酯  

Determination of AE-active lipid of Cefepime Hydrochloride for Injection by HPLC

作　　者：杜经娟 陈太煌 DU Jing-juan;CHEN Tai-huang(Haikou Nanlu Pharmaceutical Technology Co.,LTD.Hainan Haikou 570311,China)

机构地区：[1]海口南陆医药科技股份有限公司,海南海口570311

出　　处：《临床医药文献电子杂志》2019年第8期1-2,4,共3页Electronic Journal of Clinical Medical Literature

摘　　要：目的采用HPLC建立注射用盐酸头孢吡肟中AE-活性酯的质量控制方法。方法色谱柱为岛津Inertsil ODS-3 C18柱(4.6×250 mm,5μm,或者效能相当的色谱柱);以磷酸盐缓冲液(取磷酸二氢钾0.68 g,加水溶解并稀释至1000 mL)-乙腈(45:55),用2%磷酸溶液调节pH值至5.0为流动相;检测波长为220 nm;柱温为25℃;流速为1.0 mL/min;进样量为10μl,运行时间:20 min。结果供试品中未检出AE-活性酯,且AE-活性酯峰与相邻峰的分离度均符合规定,并在0.057～2.087μg/mL浓度范围内均有良好的线性关系,能满足本品的测定要求,R为0.9990;AE-活性酯的定量限为0.56 ng;回收率为100.3%。结论该方法简便准确,专属性强,可用于注射用盐酸头孢吡肟中AE-活性酯测定。Objective To establish a quality control method to detecte the AE-active lipid of Cefepime Hydrochloride for Injection by reversed-phase high performance liquid chromatography.Methods The column was Shimadazu Inertsil ODS-3(C18,5 μm,4.6×250 mm,5 μm,or the same efficiency of the chromatographic colum);The mobilephase was phosphate buffer(weighing potassium dihydrogen phosphate 0.68 g, dissolved in water and diluted to 1000 ml, shake it with vibtration)-acetonitrile(45:55), with 2 % phosphoric acid solution adjusted to pH5.0;the detection wavelength was 220nm;the temperature of Column room was 25℃;the flow was 1.0ml per minute;the injection volume was 10 μl;the running time was 20 minutes.Results The AE-active grease was not detected in the test products, the separation degree of AE-active grease from adjacent peak was in accordance with the regulation, and there was a good linear relationship within the concentration range (0.057 μg/mL)-(2.087 μg/mL), which could meet the determination requirements of the product in related substances, with R above 0.9990;The limit of quantitation of the AE-active lipid was 0.56ng;the recovery rate was 100.3%.Conclusion this method was simple, sensitive and reliable,it can be used for the determination of AE-active lipid of Cefepime Hydrochloride for Injection.

关 键 词：HPLC 盐酸头孢吡肟 AE-活性酯 

分 类 号：R942[医药卫生—药剂学]