Reverse Phase High Performance Liquid Chromatography Method for the Estimation of Mangiferin in Nano Formulations:...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Sciences

Background:

• Mangiferin (MGF) analysis requires reliable quantification methods.
• Quality by Design (QbD) principles enhance analytical method development.

Purpose of the Study:

• To develop and optimize a novel RP-HPLC method for MGF estimation using QbD.
• To validate the developed method according to ICH guidelines.
• To apply the method for stability studies and nanocarrier release kinetics.

Main Methods:

• Method screening using Taguchi Orthogonal Array (OA).
• Optimization using Box-Behnken Design (BBD) for critical factor evaluation.
• RP-HPLC separation on a C18 column with a specific mobile phase and photodiode array detection.

Main Results:

• The QbD approach successfully optimized the RP-HPLC method, ensuring robustness and reliability.
• All validation parameters (linearity, accuracy, precision, etc.) met ICH Q2-(R2) requirements.
• The method accurately analyzed MGF stability and release kinetics from SLNs.

Conclusions:

• The developed RP-HPLC method is efficient, reliable, and validated for Mangiferin quantification.
• The method is suitable for routine quality control of Mangiferin in pharmaceutical formulations, including nanocarriers.
• QbD approach significantly improved the analytical method development process.