Development and validation of stability-indicating method of etrasimod by HPLC/DAD/MS/MS technique with greenness profiling

Scientific paper - Original scientific paper

• Author: Jelena Kovačić
• Author: Daniela Amidžić Klarić
• Author: Nikša Turk
• Author: Željko Krznarić; MBZ: 75865
• Author: Ana Mornar
• Author's institution: University of Zagreb; School of Medicine; (Department of Internal Medicine)
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Clinical Medical Sciences; Internal Medicine

Abstract (english)

Etrasimod, a novel selective sphingosine-1-phosphate receptor modulator, was recently approved by the U.S. Food and Drug Administration and the European Medicinal Agency for the treatment of moderately to severely active ulcerative colitis in adults. In this research, the forced degradation study as an integral part of drug product and packaging development, which generates data on degradation mechanisms, is published. The development and validation of the stability-indicating method using a superior high-performance liquid chromatography technique coupled with a diode array detector and tandem mass spectrometer was performed to support the forced degradation study and monitor the formation of degradation products. Etrasimod demonstrated good stability under elevated temperature and basic stress conditions, while acidic hydrolysis, oxidative, and photolytic degradation produced eight degradation products. The knowledge of degradation products will be useful in the long-term stability study for establishing the acceptance criteria of etrasimod as a drug substance and dosage form during quality control and stability assessment. The eco-friendliness of the developed forced degradation procedure was evaluated using various greenness appraisal tools. The green metric tools showed that the forced degradation procedure obeys eco-friendly conditions.

• Keywords (english): Etrasimod; Forced degradation study; Green chemistry; Mass spectrometry; Stability-indicating method
• Language: english
• Publication type: Scientific paper - Original scientific paper
• Publication status: Published
• Peer review: Peer review
• Publication version: Published version
• Journal title: Heliyon
• Numbering: vol. 10, no. 13, e34066
• p-ISSN: 2405-8440
• DOI: https://doi.org/10.1016/j.heliyon.2024.e34066
• URN:NBN: urn:nbn:hr:105:946514
• Publication: 2024-07
• Document URL: https://linkinghub.elsevier.com/retrieve/pii/S2405844024100977
• Type of resource: Text
• Access conditions: Open access
• Created on: 2025-04-02 10:53:06