文章摘要
王珵,徐憬,林泽鹏,林玲.注射用盐酸头孢替安有关物质测定方法的改进[J].中国药品标准,2019,(3):205-211
注射用盐酸头孢替安有关物质测定方法的改进
Modification for the Determination Method of Related Substances in Cefotiam Hydrochloride for Injection
投稿时间:2018-12-14  修订日期:2019-05-20
DOI:
中文关键词: 注射用盐酸头孢替安  有关物质  高效液相色谱
英文关键词: Cefotiam Hydrochloride for injection  Related substances  HPLC
基金项目:
作者单位E-mail
王珵 广州市药品检验所 583566227@qq.com 
徐憬 广州市药品检验所 583566227@qq.com 
林泽鹏 广州市药品检验所  
林玲 广州市药品检验所  
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中文摘要:
      目的:改进注射用盐酸头孢替安的有关物质测定方法。方法:采用高效液相色谱法。色谱柱为Phenomenex C18色谱柱,流动相A为0.05 mol·L-1磷酸盐缓冲液(pH值7.6~7.8),流动相B为乙腈,梯度洗脱,流速为1.0 mL·min-1,柱温为25 ℃,检测波长为254 nm,进样量为20 μL。结果:在该条件下头孢替安峰与各有关物质峰分离良好。检测限为63 ng·mL-1。结论:优化后的方法采用梯度洗脱法,较等度洗脱法提高了杂质分离度和检出率;对供试品溶样液进行了比较,简化了试验操作步骤;优化了系统适用性试验条件,为其产品质量提高提供了依据。
英文摘要:
      OBJECTIVE To optimize the high performance liquid chromatography (HPLC) methods for determination of related substances in cefotiam hydrochloride for injection. METHODS HPLC was performed on the column of Phenomenex C18. The mobile phase A was 0.05 mol·L-1 phosphate buffer solution(pH 7.6~7.8), and the mobile B was acetonitrile with gradient elution. The flow rate was 1.0 mL·min-1, the column temperature was 25 ℃, the detection wavelength was 254 nm and the injection volumn was 20 μL.The related substances was calculated by self-contrast method, but the impurity A were calculated by external standard method. RESULTS The peak and impurity can be well separated. The LOD was 63 ng·mL-1. CONCLUSION The modified gradient elution method increase in impurity resolution and detectable rate than the isocratic elution. Simplify the experimental procedure with comparing the sample solution. Study out and optimize the system suitablility test condition. All of this will give a base for the quality of product improvement.
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