异丙托溴铵气雾剂中有关物质的HPLC法测定

Determination of Related Substances in Ipratropium Bromide Aerosol by HPLC

建立了高效液相色谱法测定异丙托溴铵气雾剂中的有关物质。采用SunFire C_(18)色谱柱,流动相为乙腈∶0.25%庚烷磺酸钠溶液∶三乙胺(24∶76∶0.5,用磷酸调至pH 3.2),检测波长210 nm。结果异丙托溴铵与其有关物质分离完全。异丙托溴铵在0.20~10.21μg/ml范围内线性关系良好,回收率为100.68%,RSD为1.26%。

An HPLC method was established for the determination of the related substances in ipratropium bromide aerosol. A SunFire C18 column was used, with the mobile phase of acetonitrile ： 0.25% sodium heptane sulfonate solution ＂ triethylamine （24 ：76 ： 0.5, adjusted to pH 3.2 with phosphoric acid）, at the detection wavelength of 210 nm. The related substances could be separated completely from ipratropium bromide. It was linear for ipratropium bromide in the range of 0.20--10.21μg/ml. Its average recovery was 100.68 %, with RSD of 1.26 %.