林绮丽,周劲康
LIN Qili,ZHOU Jinkang

• 1:中山市人民医院
• 2:中山新意康医药科技有限公司

摘要(Abstract)：

目的改进头孢西丁钠原料和制剂有关物质检测的HPLC方法。方法选用Phenomenex Luna C18(250 mm×4.6 mm,5μm)色谱柱,流动相:甲醇-0.2%磷酸溶液,采用梯度洗脱;检测波长:254 nm;流速:1.0 m L/min。结果本方法适用于头孢西丁钠的有关物质检测,头孢西丁主峰与相邻杂质峰分离度符合要求,其在4.95~123.75μg/m L的范围内,拟合标准曲线的线性关系良好(r=0.999 8),该检测方法的检测限(LOD)和定量限(LOQ)分别为0.329 ng和1.100 ng。结论改进后的检测方法专属性好,能快速准确检测头孢西丁钠的有关物质,检测结果同《中国药典》(2010年版)方法的结果基本相同。
OBJECTIVE To improve the detection method of related substances of Cefoxitin sodium raw material and dosage by HPLC. METHODS The Phenomenex Luna C18( 250 mm×4.6 mm,5 μm) column was used,and mobile phase was composed of Methanol-0.2% Phosphoric acid solution,by linear gradient elution,the detection wavelength was 254 nm; and the flow was 1.0 m L / min.RESULTS The method was suitable for the related substances of Cefoxitin Sodium,the main peak of Cefoxitin sodium and the other impurities peaks could be separated efficiently by this method; and Cefoxitin showed a good linearity in the range of 4.95-123.75 μg / m L( r= 0.999 8),the LOD and LOQ were 0.329 ng and 1.100 ng. CONCLUSION The improvement method is simple,accurate and reproducible,and the result is as same as the China Pharmacopoeia method( 2010).

关键词(KeyWords)： 头孢西丁钠;有关物质;HPLC;改进
Cefoxitin sodium;related substance;HPLC;improvement

Abstract:

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基金项目(Foundation):

作者(Author): 林绮丽,周劲康
LIN Qili,ZHOU Jinkang

参考文献(References)：

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