Capillary zone electrophoresis method for quantification of therapeutic peptide glatiramer acetate

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Abstract

This study presents the development and validation of a novel capillary zone electrophoresis method for the precise determination of glatiramer acetate and its amino acid constituents. A 120 mmol dm−3 phosphoric acid solution adjusted to pH 1.9 with Tris, supplemented with 20 mmol dm−3 triethylamine to achieve a final of pH 2.1, resulted in a repeatable analysis of glatiramer acetate. The method demonstrated a limit of detection and quantification of 39.2 µg cm−3 and 130.7 µg cm−3, respectively. This method allows for the rapid control of glatiramer acetate-based pharmaceuticals and distinguishes glatiramer acetate from the amino acids used in its synthesis.

Graphical abstract

Abstract Image

毛细管区带电泳法定量检测治疗肽醋酸格拉替雷
摘要 本研究开发并验证了一种新型毛细管区带电泳方法,用于精确测定醋酸格拉替雷及其氨基酸成分。用三羟甲基氨基甲烷将 120 mmol dm-3 磷酸溶液调节至 pH 1.9,再加入 20 mmol dm-3 三乙胺使最终 pH 值达到 2.1,从而实现了对醋酸格拉替雷的重复性分析。该方法的检出限和定量限分别为 39.2 µg cm-3 和 130.7 µg cm-3。该方法可快速控制醋酸格拉替雷药物,并将醋酸格拉替雷与其合成过程中使用的氨基酸区分开来。 图表摘要
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