Stability-indicating analytical approach for stability evaluation of lactoferrin

Osel, Nika (author), Planinšek Parfant, Timeja (author), Kristl, Albin (author), Roškar, Robert (author)

Lactoferrin is a multifunctional iron-binding glycoprotein in milk. Due to its potential for the treatment of various diseases, interest in products containing lactoferrin is increasing. However, as a protein, it is prone to degradation, which critically affects the quality of products. Therefore, the main purpose of our work was to develop a stability-indicating analytical approach for stability evaluation of lactoferrin. We were focused on two complementary methods: reversed-phase and size-exclusion chromatography. The stability-indicating nature of the selected methods was confirmed. They were successfully validated by following the ICH guidelines and applied to preliminary lactoferrin stability studies. Up to three degradation products, as well as aggregates and fragments of lactoferrin, were detected in various samples using complementary reversed-phase and size-exclusion chromatographic methods. The analytical approach was additionally extended with three spectroscopic techniques (absorbance, intrinsic fluorescence, and bicinchoninic acid method), which may provide valuable complementary information in some cases. The presented analytical approach allows the stability evaluation of lactoferrin in various samples, including the ability to detect differences in its degradation mechanisms. Furthermore, it has the potential to be used for the quality control of products containing lactoferrin.

• Language: English
• Keywords: lactoferrin, stability, HPLC-UV, spectroscopic methods, stability-indicating approach, proteins, quality control
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: FFA - Faculty of Pharmacy
• Publication status: Published
• Publication version: Version of Record
• Year: 2021
• Number of pages: 24 str.
• Numbering: Vol. 13, iss. 7, art. 1065
• PID: 20.500.12556/RUL-135599
• UDC: 66.022.362:535.33/.34:615
• ISSN on article: 1999-4923
• DOI: 10.3390/pharmaceutics13071065
• COBISS.SI-ID: 70061059
• Publication date in RUL: 22.03.2022

Record is a part of a journal

• Title: Pharmaceutics
• Shortened title: Pharmaceutics
• Publisher: MDPI
• ISSN: 1999-4923
• COBISS.SI-ID: 517949977

Licences

• License: CC BY 4.0, Creative Commons Attribution 4.0 International
• Link: http://creativecommons.org/licenses/by/4.0/
• Description: This is the standard Creative Commons license that gives others maximum freedom to do what they want with the work as long as they credit the author.

Secondary language

• Language: Slovenian
• Keywords: proteini, stabilnost, laktoferin, nadzor kakovosti, spektroskopska analiza

Projects

• Funder: ARRS - Slovenian Research Agency
• Project number: P1-0189
• Name: Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih

• Funder: Other - Other funder or multiple funders
• Funding programme: Support of research and development projects (TRL 3–6), S4—Networks for the transition to a circular economy, Biomass and alternative raw materials
• Name: Fractionation and processing of whey proteins and exploitation of the residue for the formation of new functional foods and food supplements
• Acronym: LAKTIKA