Analytical Method Validation For Bilastine And Montelukast Sodium Bilayered Film-Coated Tablets By Rp-Hplc Gradient Method

Abstract

The present study outlines the development and validation of a robust, precise, and accurate reverse-phase high-performance Liquid Chromatography (RP-HPLC) gradient method for the simultaneous estimation of Bilastine and Montelukast Sodium in bilayered film-coated tablet formulations. The chromatographic analysis was performed using a C18 column with a mobile phase comprising a gradient mixture of buffer and acetonitrile, monitored at an optimized wavelength. Method validation was carried out in accordance with International Council for Harmonisation (ICH) guidelines, covering parameters such as specificity, linearity, accuracy, precision, robustness, and system suitability. The developed method demonstrated excellent linearity over the concentration ranges of both drugs, with correlation coefficients (r²) close to 0.999. Accuracy was confirmed through recovery studies, yielding results within acceptable limits (98–102%). Precision studies showed low %RSD values, indicating reproducibility. The method proved to be robust under slight variations in chromatographic conditions and was capable of distinctly separating the analytes without interference from excipients. These findings confirm that the developed RP-HPLC method is suitable for the routine quality control and analysis of Bilastine and Montelukast Sodium in bilayered tablet formulations.