Reverse Phase High Performance Liquid Chromatography Method for the Estimation of Mangiferin in Nano Formulations: Development and Optimization by Analytical Quality-by-Design
Akshatha P. Kamath, Lalit Kumar, Srinivas Mutalik, Pawan Ganesh Nayak, Krishnadas Nandakumar
TL;DR
This paper presents a new HPLC method optimized using QbD for measuring mangiferin in nano-formulations, ensuring reliable and robust analysis.
Contribution
A novel RP-HPLC method for mangiferin in nano-formulations, developed and optimized using QbD and validated for quality control.
Findings
The method was validated and found to meet ICH Q2(R2) guidelines for accuracy, precision, and robustness.
The method successfully analyzed the stability and release kinetics of MGF SLNs.
The developed RP-HPLC method is suitable for routine quality control of nanocarrier systems.
Abstract
A novel reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and optimized for the estimation of Mangiferin (MGF) by employing a Quality by Design (QbD) approach. Preliminary method screening was done by the Taguchi OA, followed by using a Box–Behnken Design (BBD), enabling systematic evaluation of critical factors with a reduced number of experimental runs. The model efficiently established significant correlations between selected variables and analytical responses, thereby enhancing the method’s robustness and reliability. Chromatographic separation was achieved on a Hyperclone C18 column (4.6 × 250 mm, 5 μm) using an isocratic mobile phase consisting of phosphate buffer (pH 3.2) and acetonitrile (30%) + methanol (70%) in a 78:22% v/v ratio, at a flow rate of 1.0 mL/min. Detection was performed using a photodiode array detector at 258 nm. The method was…
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Taxonomy
TopicsMangiferin and Mango Extracts · Metabolomics and Mass Spectrometry Studies · Urban Stormwater Management Solutions