摘要
目的:建立HPLC法测定头孢拉定胶囊的强制降解产物。方法:色谱柱为Agilent C18(250 mm×4.6 mm,5μm),流动相为1%磷酸二氢铵溶液(用磷酸调节pH值到4.5):乙腈(93∶7),检测波长为254 nm,流速为0.8 mL/min,柱温为30℃。结果:在该色谱条件下,头孢拉定色谱峰与各强制降解产物色谱峰均能达到有效分离,头孢拉定在1μg/mL^100μg/mL浓度范围内线性关系良好(r=0.9999),头孢拉定胶囊粉末在高温(100℃)、光照(4500 lx)、紫外(254 nm)破坏时均较稳定,在酸、碱和氧化破坏时出现明显的杂质峰。结论:本方法操作简便、准确可靠、专属性强,可用于头孢拉定及制剂强制降解产物的杂质测定。
Objective:To establish an HPLC method for the determination of forced degradation products of Cefradine capsules.Method:The column was Agilent C18(250 mm×4.6 mm,5μm)at the temperature of 30℃.The mobile pHase was composed of 1%ammonium dihydrogen pHospHate(adjusted pH to 4.5 by pHospHoric acid):acetonitrile(93:7),the detection wavelength was 254 nm,and the flow rate was 0.8 mL/min.Results:Under the described chromatograpHic conditions,the peak of Cefradine was completely separated from the forced degradation.Good linear reladionship was observed in the concentration range of 1μg/mL^100μg/mL(r=0.9999).Cefradine capsule powder was relatively stable at high temperature(100℃),light(4500 lx)and ultraviolet(254 nm),and had obvious impurity peaks at acid,alkali and oxidation damages.Conclusion:The method is simple,specific and reliable,and it is suitable to determine impurities in Cefradine and its degradation products.
作者
张继红
郑露盼
黄道明
ZHANG Jihong;ZHENG Lupan;HUANG Daoming(Shangrao Food and Drug Inspection and Testing Center,Shangrao Jiangxi 334000,China)
出处
《药品评价》
CAS
2020年第16期18-20,30,共4页
Drug Evaluation
基金
上饶市科技局支撑项目(20194CKJ18)。
关键词
HPLC
头孢拉定胶囊
强制降解
降解产物
HPLC
Cefradine Capsules
Forced Degradation Products
Degradation Products
