This invention discloses a qualitative and quantitative
analysis method for
heparin-like components in the
biopharmaceutical field. The method includes using a liquid chromatograph, an SAX
strong anion exchange column,
sodium dihydrogen
phosphate solution as mobile phase A, and mobile phase B consisting of mobile phase A containing
sodium perchlorate, with
gradient elution for monitoring and analysis. This invention improves the separation of
heparin-like components by screening chromatographic packing materials, optimizing the chromatographic method, and optimizing the detection
wavelength. It allows for accurate
qualitative analysis of up to five
heparin components using a simple liquid
chromatography method. Furthermore, this invention incorporates the simulated separation function of the Glycomapping
glycosylation software to reconstruct the
elution peaks of components that do not reach baseline separation, and then achieves quantitative analysis of each separated component based on the external standard method. This qualitative and quantitative
analysis method provides a feasible solution for component identification and
content determination in heparin-like samples, and offers an important means for heparin
quality control.