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Stability-Indicating Analytical Approach for Stability Evaluation of Lactoferrin.

Nika Osel1, Timeja Planinšek Parfant1, Albin Kristl1

  • 1Faculty of Pharmacy, University of Ljubljana, Aškerčeva Cesta 7, 1000 Ljubljana, Slovenia.

Pharmaceutics
|August 10, 2021
PubMed
Summary

This study developed a stability-indicating analytical method for lactoferrin, a milk protein. The method uses chromatography to detect degradation products and aggregates, ensuring product quality and aiding in understanding its stability.

Keywords:
HPLC-UVlactoferrinproteinsquality controlspectroscopic methodsstabilitystability-indicating approach

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Area of Science:

  • Biochemistry
  • Analytical Chemistry
  • Food Science

Background:

  • Lactoferrin, an iron-binding glycoprotein in milk, has growing therapeutic interest.
  • Protein degradation critically impacts the quality and efficacy of lactoferrin-containing products.
  • A robust analytical method is needed for accurate lactoferrin stability assessment.

Purpose of the Study:

  • To develop and validate a stability-indicating analytical approach for lactoferrin.
  • To evaluate lactoferrin stability and identify degradation products.
  • To establish a method for quality control of lactoferrin products.

Main Methods:

  • Utilized complementary reversed-phase and size-exclusion chromatography.
  • Validated methods according to International Council for Harmonisation (ICH) guidelines.
  • Extended analytical approach with spectroscopic techniques (absorbance, fluorescence, bicinchoninic acid assay).

Main Results:

  • Confirmed the stability-indicating nature of the chromatographic methods.
  • Detected up to three degradation products, aggregates, and fragments of lactoferrin.
  • Demonstrated the ability to differentiate lactoferrin degradation mechanisms.

Conclusions:

  • The developed analytical approach enables comprehensive lactoferrin stability evaluation.
  • The method is suitable for detecting lactoferrin degradation products and structural changes.
  • This approach can be applied for quality control of lactoferrin-based products.