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.
出处
《药物分析杂志》
CAS
CSCD
北大核心
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
作者简介
Tel ： 13583184662 ; E - mail ： liuqi@ 163. com
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