反相高效液相色谱法测定两性霉素B中的相关杂质  

Determination of Related Impurity in Amphotericin B by RP-HPLC

作　　者：魏瑞萍[1] 李萍[1] 姜昕琰[1] 

机构地区：[1]上海新先锋药业有限公司,上海201203

出　　处：《抗感染药学》2008年第2期91-94,共4页Anti-infection Pharmacy

摘　　要：目的:建立高效液相色谱法分离测定两性霉素B中有关物质。方法:采用Kromasil C_(18)色谱柱(250 mm×4.6 mm,5μm);流动相(乙腈:甲醇:2.5 mmol/L EDTA=25:50:30);检测波长λ=405 nm;流速:1.0 mL/ min。结果:两性霉素B与14种相关杂质能完全分离,样品的浓度(C)在14.07～26.0μg/mL范围内与各杂质峰面积响应值(A)均呈良好的线性关系。结论:实验建立的方法简便、准确、可靠,适用于生产过程中间体、产成品杂质控制。Objective： To develop a method for determining the related impurity in amphotericin B. Methods： RP-HPLC was adopted. The column was Kromasil C18 （250 mm×4.6 mm× 5μm）, the mobile phase was acetonitrile： methanol ： 2.5 mmol/L EDTA（25 ： 50 ： 30）, and the detection wavelength was λ = 405 nm. The flow rate was 1.0 mL/ rain, Results： The related impurity can be separated from amphotericin B. There was a good linearity in the experimental concentration . Conclusion： The method is accurate and specific. It can be used for the quality control of related impurity in amphotericin B.

关 键 词：两性霉素B 高效液相色谱法 相关杂质 

分 类 号：R978.5[医药卫生—药品] R927.1[医药卫生—药学]