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。
Abstract
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.
关键词
高效毛细管电泳 /
胰岛素气雾剂 /
含量测定
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Key words
high-performance capillary electrophoresis /
insulin aerosol /
determination
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参考文献
[1]邓尚平,周文碧,熊忠云.胰岛素放射免疫分析实验条件的选择和方法学鉴定[J].四川医学院学报,1982,13(4):345.
[2]Lookabaugh M,Biswas M,Krull I.Quantitation of insulin injection by high-performance liquid chromatography and high-performance capillary electrophoresis[J].J Chromatogr,1991,549:357.
[3]Yomota C,Matsumoto Y,Okada S,et al.Diserimination limit for purity test of human insulin by capillary electrophoresis[J].J Chromatogr B,1997,703:139.
[4]Shihabi ZK,Friedberg M.Insulin stacking for capillary electrophoresis[J].J Chromatogr A,1998,807:129.
[5]毛磊.药用气雾剂[M].北京:中国医药科技出版社,1997,3~8.
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脚注
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基金
天然药物及仿生药物国家重点实验室资助课题
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