Development and validation of HPLC method for simultaneous determination of rimantadine marketed product

Abstract

This study presents the development and validation of a novel high-performance liquid chromatography (HPLC) method for the quantification of rimantadine in pharmaceutical formulations. Rimantadine, an antiviral drug primarily used in the treatment of influenza A, necessitates effective analytical methods for quality control. Our HPLC method employs a reverse-phase column with a mobile phase comprising acetonitrile and 15mM phosphate buffer (pH 3.0) and acetonitrile in the ratio of 65:35 water, under isocratic elution conditions. The detection was carried out using UV spectrophotometry at a wavelength of 270 nm. Method validation was performed in accordance with ICH guidelines, assessing parameters such as specificity, linearity, accuracy, precision, limit of detection (LOD), and limit of quantification (LOQ). The method demonstrated excellent linearity (r² > 0.999) across a wide concentration range. The precision, expressed as relative standard deviation (RSD), was below 2%, confirming the method's repeatability and reproducibility. Accuracy, tested through recovery studies, ranged from 98% to 102%. The developed method was successfully applied to analyze rimantadine in commercially available rimantadine HCl formulations, with results indicating consistent drug content within the specified limits. This validated HPLC method offers a reliable, efficient, and cost-effective approach for routine quality control analysis of rimantadine in pharmaceutical products.