HPLC法检测齐多夫定的有关物质  

HPLC Determination of the Related Substances of Zidovudine

作　　者：吴琼珠[1] 戴永健[1] 刘卫卫[1] 吴立云[1] 

机构地区：[1]第二军医大学南京军医学院药剂教研室,南京210099

出　　处：《药物分析杂志》2005年第7期856-858,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立了齐多夫定的有关物质[有关物质B(3’-氯-3’-脱氧胸苷)、有关物质C(胸苷)]的HPLC检测方法。方法:采用Lichrospher-C18色谱柱(250 mm×4.6 mm,5μm);流动相A为水,流动相B为甲醇,采用梯度洗脱,10 min后流动相 A在40 min内从70%降至30%,流速1.0 mL·min-1,检测波长265 nm。结果:有关物质B、C和齐多夫定的最低检测限量分别为4.4,2.6,4.0 ng,齐多夫定与各杂质分离良好。结论:本法简便快速,灵敏度高,准确可靠。Objective:To establish an HPLC method for detection of the zidovudine's related substances(related substance B:3'-chloro-3'-deoxynucleoside,related substance C:thymine).Methods:The analytical column was Lichrospher -C18 column(250 mm×4.6 mm,5μm). Using gradient elution method,the mobile phase A was water and the mobile phase B was methanol(ten minutes later,the mobile phase A decreased from 70% to 30% in forty minutes). The flow rate was 1.0 mL·min-1. The detection wavelength was 265 nm. Results:The detection limits for related substances B,C and zidovudine were 4. 4,2.6 and 4.0 ng respectively. Good resolution for zidovudine and related substances was obtained. Conclusions:The method is simple,rapid,sensitive and accurate.

关 键 词：有关物质 齐多夫定 HPLC法 HPLC检测方法 C18色谱柱 流动相 脱氧胸苷 梯度洗脱 检测波长 杂质分离 灵敏度 

分 类 号：R927.2[医药卫生—药学] R978.7