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文章摘要

刘雁鸣,龙海燕,彭琳,廖彬,李兰.HPLC-DAD法对注射用头孢地嗪钠杂质谱的一致性分析研究[J].中国药品标准,2013,14(3):170-173

HPLC-DAD法对注射用头孢地嗪钠杂质谱的一致性分析研究

Analysis Study on Consistency of the Impurity Profiles of Cefodizime Sodium for Injection by HPLC-DAD

投稿时间：2012-08-20

DOI：

中文关键词: 头孢地嗪钠 2-巯基-4-甲基-5-噻唑乙酸高效液相色谱法杂质谱

英文关键词: cefodizime sodium MMTA HPLC impurity profile

基金项目:

作者	单位
刘雁鸣	湖南药用辅料检验检测中心, 长沙 410014 中南大学, 长沙 410013
龙海燕	湖南药用辅料检验检测中心, 长沙 410014
彭琳	湖南药用辅料检验检测中心, 长沙 410014
廖彬	湖南药用辅料检验检测中心, 长沙 410014
李兰	湖南药用辅料检验检测中心, 长沙 410014 中南大学, 长沙 410013

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中文摘要:

目的:采用HPLC-DAD法对国产、进口和自制注射用头孢地嗪钠的杂质谱的一致性进行对比分析。方法:采用C₁₈色谱柱,以5 mmol·L^-1乙酸铵溶液为流动相A,乙腈为流动相B,梯度洗脱;流量为0.5 mL·min^-1;DAD检测器,柱温为35℃;以面积归一化法计算各杂质含量,比较自制、国产和进口样品的杂质谱,同时对各对应杂质峰的紫外特征光谱图一致性进行比较。结果:杂质峰位置、数量、每个杂质的百分含量、紫外特征光谱图和总杂质量均显示三种样品的杂质谱完全一样。结论:三种样品的杂质谱是一致的。

英文摘要:

Objective: To analyze comparatively the impurity profiles of domestic, imported and self-made cefodizime sodium for injection by HPLC-DAD. Methods: The chromatographic analysis was performed on C₁₈ column, 5 mmol·L^-1 ammonium acetate as mobile phase A and acetonitrile as mobile phase B for the gradient elution. The flow rate was 0.5 ml·min^-1. The detector was DAD, and the column temperature was 35℃. Calculate content of each impurity by the area normalization method, and compare the impurity profiles of domestic, imported and self-made cefodizime sodium for injection and meanwhile compare the consistency on UV characteristic spectra of each corresponding impurity peak. Results: The position and the number, the percentage content, the UV characteristic spectra and total content of impurity peaks showed that impurity profiles of the three samples were exactly consistent. Conclusion: The impurity profiles of the three samples were consistent.

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