Analytical Method Development And Validation For Metformin Hcl In Transdermal Patch

Abstract

The aim of the study was to develop and validate an analytical method for the estimation of the drug using High-Performance Liquid Chromatography (HPLC), and to assess its stability-indicating properties through forced degradation studies, as per the guidelines of the International Council for Harmonisation (ICH) for analytical method development and validation. Extraction was performed using phosphate buffer (pH 7.4), and analysis was carried out with a mobile phase of 1% orthophosphoric acid and acetonitrile (90:10 v/v) using a YMC C18 column. The retention time was found to be 3.4 minutes.  The method was validated per ICH Q2(R1) guidelines for specificity, linearity, accuracy, precision, robustness, and forced degradation studies. The method exhibited excellent linearity over 50–150 μg/mL with an R² > 0.999 Precision was high, with %RSD values below 2%. Accuracy, determined through recovery studies, showed results between 99% and 102.5%, aligning with the acceptable 98%–102% range. A forced degradation study was conducted under various stress conditions, including acidic, basic, oxidative, thermal, and photolytic environments. Significant degradation was observed under acidic and basic hydrolysis, and the degradation products were well-resolved from the main drug peak, demonstrating the stability-indicating capability of the method proved suitable for routine quality control analysis of Metformin in transdermal formulations.