HPLC法测定头孢他啶原料药及制剂中杂质头孢他啶叔丁酯的含量  

Content Determination of Ceftazidime t-Butyl Ester in Ceftazidime and Its Preparation by HPLC

作　　者：张冬[1] 张会兰[2] 王向红[3] 常俊山[1] 

机构地区：[1]河北省药品检验所,石家庄市050011 [2]石家庄市卫生监督局,石家庄市050051 [3]石家庄市妇幼保健院,石家庄市050091

出　　处：《中国药房》2011年第1期45-47,共3页China Pharmacy

摘　　要：目的:建立了测定头孢他啶原料药及注射用头孢他啶中杂质头孢他啶叔丁酯含量的方法。方法:采用高效液相色谱法。色谱柱为C18,流动相A、B分别为乙腈-pH7.0的磷酸盐缓冲溶液(7∶93)、(25∶75)溶液,线性梯度洗脱,检测波长为255nm。结果:头孢他啶叔丁酯检测浓度线性范围为0.01～1.22μg·μL-1,平均回收率为99.4%,RSD=1.0%。结论:该方法专属性强、快速、准确,可用于头孢他啶原料药及制剂中头孢他啶叔丁酯含量的测定。OBJECTIVE：To establish the method for the content determination of ceftazidime t-butyl ester in Ceftazidime and its preparation.METHODS：HPLC was adopted.Samples were determined on C 18 column with acetonitrile-pH 7.0 phosphate buffer solution（7∶93）as mobile phase A and acetonitrile-pH 7.0 phosphate buffer solution（25∶75）as mobile phase B（gradient elution）. UV detection wavelength was set at 255 nm.RESULTS：The linear range of ceftazidime t-butyl ester was 0.01～1.22μg·μL -1 with an average recovery of 99.4%（RSD=1.0%）.CONCLUSION：The method is specific,rapid and accurate for the content determnnation of ceftazidime t-butyl ester in Ceftazidime and its preparation.

关 键 词：头孢他啶 原料药 制剂 头孢他啶叔丁酯 高效液相色谱法 含量测定 

分 类 号：R927.1[医药卫生—药学] R978.11