HPLC法测定注射用盐酸头孢吡肟的有关物质  

HPLC Determination of Related Substances in Cefepime Hydrochloride for Injection

作　　者：田洪年 申新辉 姜鹏鹏 王墨炎 王丽霞 胡利敏 任峰 TIAN Hong-nian;SHEN Xin-hui;JIANG Peng-peng;WANG Mo-yan;WANG Li-xia;HU Li-min;REN Feng(Hebei Hejia Pharmaceutical Technology Group Co.,Ltd.,Shijiazhuang 052165,China;Hebei Hejia Pharmaceutical Science and Technology Group,Hejia Research Institute,Shijiazhuang 052165,China)

机构地区：[1]河北合佳医药科技集团股份有限公司,河北石家庄052165 [2]河北合佳医药科技集团合佳研究院,河北石家庄052165

出　　处：《精细化工中间体》2025年第1期74-78,83,共6页Fine Chemical Intermediates

摘　　要：建立高效液相色谱法测定注射用盐酸头孢吡肟的有关物质。采用GL Sciences Inertsil ODS-3色谱柱,检测波长254 nm,流速1.0 mL/min,柱温40℃,流动相A为5 mmol/L磷酸盐缓冲液(pH=5.0)-乙腈(体积比93:7),流动相B为5 mmol/L磷酸盐缓冲液(pH=5.0)-乙腈(体积比50∶50),梯度洗脱程序。该方法空白溶剂和空白辅料对有关物质检测无干扰;供试品中主成分出峰时间与对照品一致;各物质在LOQ浓度至250%限度浓度范围内,峰面积与浓度呈良好线性关系,相关系数r均大于0.999;准确度高,回收率均在94.0%~112.0%;检测限、定量限可以满足实验要求;耐用性好。方法简单,快速,准确,专属性强,可以用于注射用盐酸头孢吡肟有关物质的检测。To establish a high performance liquid chromatography(HPLC) method for determining related substances in cefepime hydrochloride for injection,the detection of relevant substances was carried out using GL Sciences Inertsil ODS-3 chromatography column,with a detection wavelength of 254 nm,a flow rate of 1.0 mL/min,and a column temperature of 40 ℃.The mobile phase A was 5 mmol/L phosphate buffer(pH=5.0)-acetonitrile(the volume ratio was93∶7),and the mobile phase B was 5 mmol/L phosphate buffer(pH=5.0)-acetonitrile(the volume ratio was 50∶50).The gradient elution procedure was employed.The blank solvent and blank excipients of this method showed no interference with the detection of relevant substances.The retention time of the main components of the test sample is consistent with that of the control sample.Within the range from the limit of quantification(LOQ) to 250% of the limit concentration,there is a good linear relationship between peak area and concentration for each substance,and the correlation coefficient r is greater than 0.999.The method demonstrated high accuracy,with recovery rates ranging from 94.0% to 112.0%,and the detection limit and quantification limit can meet the experimental requirements,exhibiting good durability.This method is simple,fast,accurate,and highly specific,making it suitable for detecting substances related to cefepime hydrochloride for injection.

关 键 词：HPLC法 盐酸头孢吡肟 有关物质 

分 类 号：TQ460.7[化学工程—制药化工] R978.1[医药卫生—药品] O657.7[医药卫生—药学]