HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR POLYPEPTIDE MIXTURES

摘要

Provided is a high performance liquid chromatography method for polypeptide mixtures. Specifically, the method comprises the following steps of (1) formulating a Glatiramer acetate solution to be tested; (2) subjecting the sample to be tested to gradient elution by way of anion exchange liquid chromatography, cation exchange liquid chromatography or reversed-phase liquid chromatography; and (3) detecting and analyzing peak areas corresponding to various components of the copolymer, and by means of comparison with a control, determining whether the content ranges of the various components in the sample to be tested are qualified.