Stability of furosemide in aqueous systems

Area of Science:

• Analytical Chemistry
• Pharmaceutical Sciences
• Drug Stability

Background:

• Furosemide is a critical diuretic medication.
• Understanding furosemide's stability is essential for ensuring its efficacy and safety.
• Existing analytical methods may not fully capture degradation pathways.

Purpose of the Study:

• To develop and validate a stability-indicating assay for furosemide.
• To investigate the degradation kinetics of furosemide under various stress conditions.
• To identify furosemide decomposition products.

Main Methods:

• High-Performance Liquid Chromatography (HPLC) was employed for assay development.
• Method validation included assessments of sensitivity, accuracy, and precision (standard deviation +/- 1.37%).
• Stability studies involved diverse aqueous solutions, dosage forms, temperatures (room, 45°C, 65°C, 85°C), pH values, and vehicles.

Main Results:

• A sensitive, accurate, and precise stability-indicating HPLC assay for furosemide was successfully developed.
• Furosemide stability was evaluated across a range of environmental and formulation conditions.
• Key decomposition products of furosemide were identified.

Conclusions:

• The developed HPLC method provides a reliable tool for furosemide stability assessment.
• The study elucidates furosemide's degradation behavior, informing pharmaceutical development.
• This research contributes to optimizing furosemide formulations for enhanced shelf-life and therapeutic performance.