高效液相色谱法对盐酸乙胺丁醇片中有关物质的评价  

Evalutaion of Related Substances in Ethambutol Hydrochloride Tablets by HPLC

作　　者：张瑜 裘一兰 王冬 

机构地区：[1]辽宁省大连市食品药品检验所,辽宁大连116021

出　　处：《中国药业》2013年第10期63-64,共2页China Pharmaceuticals

摘　　要：目的建立测定盐酸乙胺丁醇片中杂质内消旋盐酸乙胺丁醇(杂质B)的高效液相色谱法,对15个厂家52批样品的有关物质进行评价。方法色谱柱为Inertsil ODS3柱(100 mm×4.6 mm,3μm),流动相为甲醇-水(1∶1)和水的梯度洗脱,检测波长为215 nm,以(R)-(+)-1-苯乙基异氰酸酯为柱前衍生化试剂,流速为1.0 mL/min,柱温为40℃。结果盐酸乙胺丁醇和杂质B的衍生物分离度良好,最低检出限为0.05μg/mL。结论该方法专属性强,准确,灵敏,可用于盐酸乙胺丁醇片中有关物质的质量控制。Objective To establish a HPLC method to determine the impurity meso- ethambutol hydrochloride（impurity B） in Ethambutol Hydrochloride Tablets and to evaluate the related substances in 52 samples from 15 pharmacy companies. Methods The chromatograph- ic column was the Inertsil ODS- 3 column（100 mm ×4.6 mm,3μm）. The mobile phase was methanol：water（1：1） with the gradient elution. The detection wavelength was set at 215 nm. （R）- （＋）- 1- phenylethyl isocyanate was used as the pre-colmn derivatization reagent. The flow rate was 1.0 mL/min and the column temperature was 40 ℃. Results The separation degree of ethambutol hy- drochloride and impurity B derivatives was good, and their limit of detection（LOD） was 0.05μg/mL. Conclusion This method is strongly specific, accurate and sensitive, so which could be used for the quality control of the related substances in Ethambutol Hy- drochloride Tablets.

关 键 词：盐酸乙胺丁醇 高效液相色谱法 (R)-(+)-1-苯乙基异氰酸酯 柱前衍生化 

分 类 号：R927.11[医药卫生—药学] R978.3