高效液相色谱法测定喹红霉素的有关物质  

Determination of related substances in cethromycin by HPLC

作　　者：李成龙[1] 王宇驰 孙样 张春然[1] 唐克慧[1] 

机构地区：[1]成都大学四川抗菌素工业研究所,成都610052

出　　处：《中国抗生素杂志》2015年第4期264-267,共4页Chinese Journal of Antibiotics

摘　　要：目的 建立高效液相色谱法测定喹红霉素的有关物质.方法 采用Inertsil ODS-3（150mm×4.6rnm,5μm）色谱柱,流动相A为磷酸盐缓冲液（0.04mol/L的磷酸氢二钾溶液,20％的磷酸调节pH至5.8）,流动相B为乙腈,梯度洗脱;流速为lmL/mim检测波长为250nm;柱温为35℃;进样体积为10μL.结果 喹红霉素与各有关物质分离良好;在0.1007-40.28μg/mL浓度范围内,峰面积与浓度呈良好的线性关系,相关系数为0.9999;检测限为0.25ng,相当于0.0025％杂质量.结论 该方法简便、灵敏、专属、可靠,可用于喹红霉素有关物质的测定.Objective To establish an HPLC method for the determination of related substances in cethromycin. Methods Separation was performed on a Inertsil ODS-3 column（150mm × 4.6mm, 5μm）. Mobile phase A was phosphate buffer solution（0.04mol/L monopotassium phosphate, adjust pH to 5.8 by adding 20% phosphate）, mobile phase B was acetonitrile, gradient elution was performed at a flow rate of 1.0mL/min. The detection wavelength was 250nm.The column temperature was maintained at 35℃. The injection volume was 10μL. Results Cethromycin was completely separated from related substances; The linear range of the method was 0.1007-40.28μg/mL with a correlation coefficient of 0.9999. The limit of detection was 0.25ng. Conclusion This method was simple, sensitive, selective and reliable, and can be used for the determination of related substances of cethromycin.

关 键 词：高效液相色谱法 喹红霉素 有关物质 

分 类 号：R978.15[医药卫生—药品]