Capillary zone electrophoresis method for quantification of therapeutic peptide glatiramer acetate

Abstract

AbstractThis 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