高效液相色谱法测定美法仑中的有关物质  

Determination of Related Substances in Melphalan by HPLC

作　　者：王增仙[1] 甄会贤[1] 高萧枫[1] 武敏霞[1] 李平[1] 

机构地区：[1]山西生物应用职业技术学院,山西太原030031

出　　处：《山西职工医学院学报》2012年第1期8-10,共3页Journal of Shanxi Medical College for Continuing Education

摘　　要：目的:建立反相高效液相色谱法测定美法仑中的有关物质。方法:采用Diamonsil ODS(4.6 mm×150 mm,5μm)色谱柱,流动相为0.375%碳酸铵的水溶液∶乙腈∶冰醋酸(100∶35∶1.0),流速为1.0 mL/min,检测波长为260 nm。结果:美法仑主要成分峰与其有关物质完全分离,在0.000 002 6～0.002 mg/mL范围内线性关系良好,检测限(S/N≥3)为0.8 ng/mL。结论:此方法准确、可靠,可用于美法仑有关物质的考察。Objective ： To establish a RP-HPLC method for the determination of related substances in Melphalan. Methods： The chromatography column used was diamonsil ODS （4.6 × 150 mm 5 μm）. The mobile phase was made up of the 0. 375 % salvolatile aqueous solution , acetonitrile and icy acetic acid （ 100： 35： 1.0）. The mobile speed was 1. 0 mL/min. The detection wavelengths was 260 nm. Results： The main elements （ peak and related substances in Melphalan） were completely seperated. The good linear relationship in a range of 0. 000 002 6 - 0. 002 mg/mL was built. The detection limit（S/N≥3） was 0.8 ng/mL. Conclusion： This method is accurate, reliable, and can be used for the study of related substances in Melphalan.

关 键 词：美法仑 反相高效液相色谱法 有关物质 

分 类 号：R927.2[医药卫生—药学]