高效毛细管电泳法测定胰岛素气雾剂的含量

 目的 建立以高效毛细管电泳法测定胰岛素气雾剂的含量。方法 采用高效毛细管电泳法，缓冲液系统为硼酸盐(20 mmol·L^-1)-Tris(20 mmol·L^-1)-Triton X-100 (2%),pH=8.20，检测波长为214 nm。结果 在19.0～228 μg·mL^-1间线性良好，相关系数r=0.9991。高、中、低3种浓度的加样回收率在94.7%～106.8%之间，日内和日间RSD低于4%，胰岛素的最低浓度为0.8 μg·mL^-1。结论 本方法能简单、快速、经济地测出胰岛素气雾剂的含量，可用于类似药物制剂的质量控制和含量测定。

Determination of insulin in aerosol by high-performance capillary electrophoresis

OBJECTIVE To establish a sensitive method to determine insulin in a newly developed aerosol by high-performance capillary electrophoresis (HPCE).METHODS The concentration of insulin was determined by HPCE in the buffer system of borate-Tris-Triton(20 mmol·L^-1∶20mmol·L^-1∶2% with pH8.20) and was detected at 214 nm.RESULTS The linear range of this method was 19.0～228 μg·mL^-1,with a correlation coefficient of 0.9991.The recovery was 94.7%～106.8%,the within-day and between-day precision were both below 4%.The limit of detection of insulin was 0.8 μg·mL^-1.CONCLUSION This method appeared to be simple with good reproducibility,and provided a rapid,economic and effective approach for quality control and quantitative analysis of this kind of medicine in similar formulation.