中国药房2013，Vol.24Issue(25)：2383-2386,4.DOI:10.6039/j.issn.1001-0408.2013.25.29
五水头孢唑林钠与头孢唑林钠中杂质含量的比较研究
Comparison Study of Impurity Contents of Cefazolin Sodium Pentahydrate and Cefazolin Sodium
陈永刚 1马传学 1杨青 1刘晓玲 1李璠 1吕祥 2孙远锋2
作者信息
- 1. 徐州市中心医院临床药学部,江苏徐州221009
- 2. 徐州医学院药学院,江苏徐州221004
- 折叠
摘要
Abstract
OBJECTIVE:To study the difference in impurity contents of cefazolin sodium pentahydrate and cefazolin sodium.METHODS:HPLC method was adopted.The determination was performed on Agilent Zorbax SB-C18 column with mobile phase of 0.02 mol/L ammonium acetate aqueous solution (A)-methanol (B) (gradient elution) at the flow rate of 1.0 ml/min.The detection wavelength was set at 254 nm,and column temperature was 30 ℃.The quantitative analysis of impurities was carried out with main component self-comparison method and specified impurity with external standard method.RESULTS:Results of established determination methodology was in line with the requirements of Chinese Pharmacopeia.Among 3 batches of cefazolin sodium pentahydrate for injection (same manufacturer) and 7 batches of cefazolin sodium for injection (different manufacturers),the content of single impurity was less than or equal to 0.42％ and the total content of 19 impurities were less than or equal to 1.66％,which were conforming to the impurity limit requirement in Chinese Pharmacopoeia.Meanwhile,the number and content of impurities of cefazolin sodium pentahydrate were less than those of cefazolin sodium.CONCLUSIONS:Impurity contents of cefazolin sodium pentahydrate are significantly lower than those of cefazolin sodium.The developed method is simple,feasible,accurate and reliable,which is helpful to control the impurity of cefazolin sodium pentahydrate and cefazolin sodium.关键词
高效液相色谱法/注射用五水头孢唑林钠/注射用头孢唑林钠/杂质/含量Key words
HPLC/ Cefazolin sodium pentahydrate for injection/ Cefazolin sodium for injection/ Impurity/ Content分类
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陈永刚,马传学,杨青,刘晓玲,李璠,吕祥,孙远锋..五水头孢唑林钠与头孢唑林钠中杂质含量的比较研究[J].中国药房,2013,24(25):2383-2386,4.
