HPLC法测定地西他滨有关物质的研究  

Determination of related substances in Decitabine by HPLC

作　　者：袁玉[1] 吉同琴[1] 

机构地区：[1]江苏省南京市江苏奥赛康药业股份有限公司,江苏南京211112

出　　处：《中国当代医药》2012年第19期83-84,共2页China Modern Medicine

摘　　要：目的建立测定地西他滨有关物质的HPLC法。方法采用Kromasil C18柱(250 mm×4.6 mm,5μm),以0.01 mol/LK2HPO4溶液(用1.0 mol/L HCl调节pH值为6.0),流速为1.0 mL/min,柱温为(25±2)℃,检测波长为220 nm。结果溶剂甲醇对有关物质检查无干扰,主成分峰的理论塔板数大于2 000,且与杂质峰的分离度符合规定。结论该法专属性强、结果准确可靠,可用于地西他滨有关物质的测定。Objective To establish an HPLC method for the determination of related substances in decitabine. Methods The method was performed on Kromasil Cl8 column （250 mm×4.6 mm, 5 μm）, the mobile phase was 0.01 mol/L, K2HPO4 （pH value 6.0 achieved by 1.0 mol/L HC1）, the flow rate was 1.0 mL/min,the column temperature was （25＋2）℃ and the wavelength was 220 nm. Results Methanol did not disturb the determination of related substances. Theoretical plate num- ber of the main peak was more than 2 000, and the resolution between the main peak and impurity peak was accord with the set. Conclusion The method is specific, accurate and reliable, it is suitable to the determination of related substances in decitabine.

关 键 词：高效液相色谱法 地西他滨 有关物质 专属性 

分 类 号：R92[医药卫生—药学]