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

作　　者：张依 兰公剑 邹泓 ZHANG Yi;LAN Gong-jian;ZOU Hong(Research Institute of Nanjing Chia Tai Tianqing Pharmaceutical Co.Ltd.,Nanjing 210046,China)

机构地区：[1]南京正大天晴制药有限公司研究院分析所,江苏南京210046

出　　处：《安徽化工》2024年第4期135-137,共3页Anhui Chemical Industry

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(250 mm×4.6 mm,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:1.0 mL·min^(-1);检测波长:254 nm;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=0.999 9),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。Objective:To establish a HPLC method for the determination of the related substances of 4-demethoxydaunoru-bicin.Methods:A W elch Utimate AQ-C18(250 mm×4.6 mm,5μm)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 0.15~2.45μg·mL^(-1)(r=0.9999),and the LOD was 0.021μg·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 

分 类 号：R927.11[医药卫生—药学]