高效液相色谱法测定4-脱甲氧柔红霉素有关物质
Determination of the Related Substances of 4-Demethoxydaunorubicin by HPLC
张依 1兰公剑 1邹泓1
作者信息
- 1. 南京正大天晴制药有限公司研究院分析所,江苏南京 210046
- 折叠
摘要
目的:建立4-脱甲氧柔红霉素有关物质检查的高效液相色谱方法.方法:采用十八烷基硅烷键合硅胶为填料的Welch Ultimate AQ-C18(250mm×4.6mm,5μm)色谱柱对杂质进行定量分析;以0.1％磷酸水溶液为流动相A,以甲醇-乙腈(50∶50)为流动相B;流速:1.0mL·min-1;检测波长:254nm;柱温:35℃.结果:主峰与杂质峰、各杂质峰间均能达到基线分离.4-脱甲氧柔红霉素在0.15～2.45μg·mL-1浓度范围内与峰面积呈良好的线性关系(r=0.9999),检测限为0.021μg·mL-1.结论:该方法灵敏、准确,专属性良好,适用于4-脱甲氧柔红霉素的质量控制.
Abstract
Objective:To establish a HPLC method for the determination of the related substances of 4-demethoxydaunoru-bicin. Methods:A Welch Ultimate AQ-C18 (250 mm×4.6 mm,5 μm) column was selected for the separation of impurities. 0.1％ Phosphoric acid solution was used as the mobile phase A,and the mobile phase B was consisted of methanol-acetonitrile (50∶50). The flow rate was 1.0 mL·min-1,and the detection wavelength was 254 nm,and the column tempera-ture was 35℃. Results:The chief peak and every impurity peak were separated well. A good linearity for 4-demethoxydau-norubicin was obtained over the range of 0.15～2.45 μg·mL-1 (r=0.9999),and the LOD was 0.021 μg·mL-1. Conclusion:The method is sensitive,accurate,and suitable for quality control of 4-demethoxydaunorubicin.
关键词
4-脱甲氧柔红霉素/HPLC法/有关物质Key words
4-demethoxydaunorubicin/HPLC method/related substances引用本文复制引用
出版年
2024
NETL
NSTL
万方数据