Quantitation of insulin by capillary electrophoresis and high-performance liquid chromatography Method comparison and validation

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• 作者：Kunkel ; Annette ; Gü ; nter ; Stefan ; Dette ; Christoph ; Wä ; tzig ; Hermann
• 关键词：Validation ; Pharmaceutical analysis ; Insulin ; Hormones ; Peptides
• 刊名：Journal of Chromatography A
• 出版年：1997
• 出版时间：September 26, 1997
• 年：1997
• 卷：781
• 期：1-2
• 页码：445-455
• 全文大小：735 K

文摘

Two validated high-performance liquid chromatography (HPLC) and capillary electrophoresis (CE) assays for insulin are compared. Both methods are selective and robust, with best reproducibility in a 0.9 % sodium chloride solution, pH 7-8, as the sample solvent. It is shown that, besides sample solvent and buffer pH, acetonitrile volatility is a crucial point for reproducibility. Its high importance for selectivity and ruggedness is also stressed. Trends have been extensively investigated and characterized. The separation efficiency is better for the CE method. Furthermore, the analysis time of the CE method is up to four times shorter than the respective parameter in HPLC and the acetonitrile consumption is more than 100-fold less. Earlier works stated that all relevant precision data, such as relative signal standard deviation (1.6 % R.S.D. for peak areas, n