摘要
目的:建立高效液相色谱法测定注射用头孢米诺钠中有关物质的测定方法。方法:采用Inertsil Ph-3色谱柱(4.6 mm×250 mm,3μm),流动相A为pH值2.5的甲酸铵溶液,流动相B为乙腈,梯度洗脱;柱温为35℃;检测波长为254 nm;流速为1.0 mL/min。结果:该方法下主峰与各杂质峰之间的分离良好,头孢米诺及12种杂质在各自浓度范围内,溶液浓度和峰面积呈良好的线性关系(r≥0.999);12种杂质的平均回收率在95.0%~105.0%范围内,RSD(n=9)<3.0%;定量限、检出限、耐用性等均符合要求。结论:该方法专属性强、灵敏度高、准确度高,可有效检出注射用头孢米诺钠中12种杂质的含量。通过与进口注册标准或中国药典中收载的注射用头孢米诺钠中有关物质的检测方法相比,该方法对杂质的检出能力更强,适用于注射用头孢米诺中有关物质的检测。
Objective:To establish a HPLC method for the determination of related substances in cefminox sodium for Injection.Methods:The analytical column was Inertsil Ph-3(4.6 mm×250 mm,3μm);Mobile phase a was ammonium formate solution with pH 2.5,mobile phase B was acetonitrile,gradient elution.The column temperature was 35℃,the detective wavelength was 254nm,and the flow rate was about 1.0 mL/min.Results:The related impurities and the main components can be effectively separated in this method,cefminox and 12 kinds of impurities within their respective concentration and peak area show a good linearity(r≥0.999);The average recovery rate is in 95.0%~105.0%,RSD(n=9)<3.0%;The limit of quantification,detection limit,durability,etc.all meet the requirements.Conclusion:The method is specificity,sensitive,and accurate for the determination of related substances,and it can effectively detect 12 kinds of impurities in cefminore sodium for injection;Compared with cefminore sodium for injection contained in import registration standard or Chinese pharmacopoeia,this method has stronger detection ability of various impurities,suitable for the detection of related substances in cefminol for injection.
作者
董娟
刘姣
满彦汝
李园园
Dong Juan;Liu Jiao;Man Yanru;Li Yuanyuan(Shandong Lukang Pharmaceutical Co.,Ltd.,Jining 272100,China)
出处
《山东化工》
CAS
2024年第4期139-144,共6页
Shandong Chemical Industry
