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

Area of Science:

• Pharmaceutical Sciences
• Drug Development
• Analytical Chemistry

Background:

• Etrasimod is a novel sphingosine-1-phosphate receptor modulator approved for ulcerative colitis.
• Forced degradation studies are crucial for drug product and packaging development.
• Understanding degradation mechanisms informs stability assessment and quality control.

Purpose of the Study:

• To conduct a forced degradation study on etrasimod.
• To develop and validate a stability-indicating analytical method.
• To assess the environmental impact of the degradation procedure.

Main Methods:

• High-performance liquid chromatography (HPLC) coupled with a diode array detector (DAD) and tandem mass spectrometry (MS/MS).
• Forced degradation under various stress conditions: elevated temperature, basic, acidic, oxidative, and photolytic.
• Validation of the stability-indicating method.
• Evaluation of eco-friendliness using greenness appraisal tools.

Main Results:

• Etrasimod exhibited good stability under elevated temperature and basic conditions.
• Acidic hydrolysis, oxidative, and photolytic stress generated eight degradation products.
• The developed HPLC-DAD-MS/MS method was validated for stability indicating.
• The forced degradation procedure was confirmed to be eco-friendly.

Conclusions:

• The forced degradation study provides essential data on etrasimod's degradation pathways.
• Knowledge of degradation products aids in establishing acceptance criteria for drug substance and dosage form.
• The validated analytical method supports long-term stability studies and quality control.
• The employed forced degradation procedure aligns with green chemistry principles.