Stability-Indicating Analytical Approach for Stability Evaluation of Lactoferrin

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.