High-Performance Liquid Chromatography (HPLC) Method Validation for Identifying and Quantifying Rebamipide in...

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Nanotechnology

Background:

• Rebamipide, a quinolinone derivative, shows therapeutic potential for dry eye but suffers from low bioavailability and vision clouding.
• Ethosomes, lipid-based nanovesicles, offer a promising strategy to enhance ocular drug delivery and overcome rebamipide's limitations.

Purpose of the Study:

• To develop and validate a robust, high-performance liquid chromatography (HPLC) method for quantifying rebamipide encapsulated in ethosomes.
• To assess the entrapment efficiency, drug content, and drug release kinetics of rebamipide-loaded ethosomes.

Main Methods:

• Development of a specific, linear, accurate, and precise HPLC method for rebamipide analysis.
• Preparation of rebamipide ethosomes using the film hydrating method.
• Validation of the HPLC method according to International Conference of Harmonization (ICH) guidelines, including system suitability, specificity, linearity, accuracy, precision, LOD, and LOQ determination.

Main Results:

• The HPLC method demonstrated excellent linearity, specificity, and system suitability within the 4-24 µg/ml concentration range.
• Rebamipide ethosomes exhibited an entrapment efficiency of 76% ± 7 and drug content of 93% ± 6.
• Drug release followed zero-order kinetics, with recovery rates between 90-100% and low %RSD values confirming precision. LOD and LOQ were 1.04 μg/mL and 3.16 μg/mL, respectively.

Conclusions:

• The developed HPLC method is suitable for the rapid and accurate quantitative determination of rebamipide in ethosomes.
• The validated method provides a reliable analytical tool for pharmaceutical research and development of advanced ocular drug delivery systems.
• This study contributes to the advancement of ethosomal formulations for enhanced ocular bioavailability of therapeutic agents like rebamipide.