Validation of an Analytical Method for the Simultaneous Determination of Hyaluronic Acid Concentration and Molecular Weight by Size-Exclusion Chromatography

Molecules. 2021 Sep 3;26(17):5360. doi: 10.3390/molecules26175360.

Abstract

The hyaluronic acid (HA) global market growth can be attributed to its use in medical, cosmetic, and pharmaceutical applications; thus, it is important to have validated, analytical methods to ensure confidence and security of its use (and to save time and resources). In this work, a size-exclusion chromatography method (HPLC-SEC) was validated to determine the concentration and molecular distribution of HA simultaneously. Analytical curves were developed for concentration and molecular weight in the ranges of 100-1000 mg/L and 0.011-2.200 MDa, respectively. The HPLC-SEC method showed repeatability and reproducibility greater than 98% and limits of detection and quantification of 12 and 42 mg/L, respectively, and was successfully applied to the analysis of HA from a bacterial culture, as well as cosmetic, and pharmaceutical products.

Keywords: Streptococcus zooepidemicus; analytical method; hyaluronic acid; molecular weight distribution; size-exclusion chromatography.

Publication types

  • Validation Study

MeSH terms

  • Chromatography, Gel*
  • Hyaluronic Acid / analysis*
  • Molecular Weight
  • Particle Size

Substances

  • Hyaluronic Acid