Development and Validation of a Stability-Indicating RP-HPLC Method for Edaravone Quantification.

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Neuroscience

Background:

• Edaravone is a critical treatment for motor neurone disease (MND), available as IV infusion and oral suspension.
• Developing novel edaravone formulations necessitates a validated stability-indicating assay for accurate quantification.
• Existing analytical methods may not fully meet the requirements for new drug development.

Purpose of the Study:

• To develop and validate a stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for edaravone.
• To ensure the method provides specific, precise, and accurate quantification of edaravone content.
• To support the development of new edaravone formulations.

Main Methods:

• Evaluation of ten RP-HPLC methods based on published literature.
• Optimization of chromatographic conditions using a gradient method on an Agilent ZORBAX Extend-C18 column.
• Validation of the method according to ICH Q2(R2) guidelines for specificity, linearity, sensitivity, accuracy, and precision.

Main Results:

• A robust RP-HPLC method was developed, achieving excellent separation of edaravone from impurities and degradants.
• The method demonstrated high precision and accuracy within the concentration range of 6.8-68.6 µg/mL.
• The assay was recommended for use without methyl hydroxybenzoate (MHB) as an internal standard.

Conclusions:

• The developed stability-indicating RP-HPLC method is suitable for quantifying edaravone in various formulations.
• This validated assay is essential for quality control and stability testing during the development of novel edaravone products.
• The method's specificity and accuracy support ongoing research into improved edaravone treatments for MND.