HPLC法测定布地奈德气雾剂的含量和有关物质  

Determination of the content and related substances of budesonide aerosol by HPLC

作　　者：刘琦[1] 梁翠荣[1] 谢元超[1] 徐玉文[1] 王志军[2] 

机构地区：[1]山东省食品药品检验所,济南250101 [2]国家药典委员会,北京100061

出　　处：《药物分析杂志》2014年第3期471-474,共4页Chinese Journal of Pharmaceutical Analysis

基　　金：国家药典委员会"气雾剂品种质量标准提高"专项课题;编号2011-668

摘　　要：目的:建立布地奈德气雾剂含量测定和有关物质检查的HPLC方法。方法:采用Kromasil C18色谱柱(4.6 mm×250 mm,5μm),以磷酸盐缓冲液(pH 3.2)-乙腈(58∶42)为流动相,流速1.0 mL·min-1,检测波长246 nm,柱温35℃,进样量20μL。结果:各降解产物均可与布地奈德主峰良好分离,方法的精密度和重复性良好(RSD<0.2%)。结论:该方法可检测布地奈德异构体AB,适用于布地奈德气雾剂的质量控制。Objective ：To establish an HPLC method for the determination of the content and related substances of budesonide aerosol. Methods：A Kromasil C18 column （4.6 mm x250 mm,5 μm） was used with a mixture of phosphate buffer （pH 3.2） and acetonitrile （58：42） as the mobile phase. The flow rate was 1.0 mL · min-1 and the detection wavelength was 246 nm, the temperature of the column was 35 ℃, the injection volume was 20 μL. Results： An excellent separation was achieved for budesonide and its related substances. The reproduc- ibility and precision of the method were good （RSD 〈 0.2% ）. Conclusion：This method can be used for deter- mining the related isomer A and B of budesonide aerosol. It is also suitable for the quality control for budes- onide aerosol.

关 键 词：布地奈德 布地奈德异构体AB 杂质检测 高效液相色谱法 气雾剂质量控制 

分 类 号：R917[医药卫生—药物分析学]