反相高效液相色谱法测定氯霉素及其相关物质  

Simultaneous determination of chloramphenicol and its hydrolytic and photolytic products by RP-HPLC

作　　者：李静 胡昌勤[2] 杭太俊[3] 

机构地区：[1]山东省药品检验所,济南250012 [2]中国药品生物制品检定所,北京100050 [3]中国药科大学药学院,南京210009

出　　处：《中国抗生素杂志》2004年第6期341-345,共5页Chinese Journal of Antibiotics

摘　　要：目的　 HPL C法同时测定氯霉素、二醇物及氯霉素光降解产物 ,更好地监控氯霉素尤其是氯霉素溶液制剂的质量。方法　ODS色谱柱 (15 0 mm× 4 .6 mm,5 μm) ;流动相为 0 .15 %己烷磺酸钠溶液 (用 0 .1%冰HAc溶液调节 p H3.7) -乙腈 (75∶ 2 5 ) ;紫外检测。比较了文献报道的不同流动相系统对氯霉素及水解、光解产物分离的影响 ,同时考查研究了 p H、离子对种类、离子对浓度等因素对分离的影响。结果　含离子对流动相可以提高二醇物的保留时间 ;p H对氯霉素及二醇物色谱峰影响较小 ,但对氯霉素光降解物色谱峰影响较大。结论　确定了同时检测氯霉素、二醇物及氯霉素光降解产物含量变化的 HPL C系统 ,方法简便 ,分离效果好。A reverse phase HPLC method has been developed to determine chloramphenicol and its hydrolytic and photolytic products simultaneously. The chromatographic conditions were as follows: column: ODS column(150mm×4.6mm,5μm);mobile phase: 0.15% sodium hexanesulfonate solution (adjusted to pH3.7 with 0.1% HAc)∶acetonitrile (75∶25);flow rate: 1.0ml/min;UV detection at 272 nm. In this article,effects on the seperation of chloramphenicol and its related substances were compared using different mobile phase systems reported in the literatures,and the effects of pH,the sort and concentration of ion pair solvent on the separation were investigated. It showed that the mobile phase containing ion pair can prolong the retention of the hydrolytic product;pH value had little effect on the peak profiles of chloramphenicol and its hydrolytic product,but much influenced the photolytic product. The method is simple,rapid and reproducible. It can be applied to monitor the quality and stability of chloramphenicol and its preparations.

关 键 词：高效液相色谱 氯霉素 二醇物 氯霉素光降解物 

分 类 号：R978.13[医药卫生—药品] O652.63[医药卫生—药学]