高效毛细管电泳法测定胰岛素气雾剂的含量

Determination of insulin in aerosol by high-performance capillary electrophoresis

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 (2 0mmol·L-1) Tris(2 0mmol·L-1) TritonX 10 0 (2 % ) ,pH =8.2 0 ,检测波长为 2 14nm。结果 在 19.0～ 2 2 8μg·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%～ 10 6 .8%之间 ,日内和日间RSD低于 4% ,胰岛素的最低浓度为0 .8μg·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 。

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&middotL-1:20mmol&middotL-1:2% with pH8.20) and was detected at 214 nm. RESULTS: The linear range of this method was 19.0 ∼ 228 μg&middot 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&middotmL-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.