Validated RP-HPLC Method for Determination of Cetirizine and Montelukast in Bulk and Pharmaceutical Formulation

Abstract

A precise, rapid, and reproducible Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Cetirizine and Montelukast in both bulk drug substances and pharmaceutical formulations. The chromatographic separation was carried out using a Phenomenex Luna C18column (4.6 × 150mm, 5μm) maintained at a temperature of 35°C. The optimized mobile phase consisted of Methanol and Water in the ratio of 70:30 v/v, delivered at a flow rate of 1.0 mL/min.Detection was performed at a wavelength of 230 nm, with a 10µL injection volume and a total run time of 10minutes. Both drugs were effectively separated with sharp, symmetrical peaks and satisfactory retention times. The method was validated according to ICH guidelines, demonstrating acceptable results for linearity, accuracy, precision, robustness, specificity, and system suitability.