HPLC法测定布地奈德气雾剂的含量和有关物质

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，5 μm），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20 μL。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×250 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 reproducibility and precision of the method were good (RSD<0.2%). Conclusion: This method can be used for determining the related isomer A and B of budesonide aerosol.It is also suitable for the quality control for budesonide aerosol.

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