RP-HPLC Method and Its Validation for Analysis of Fexofenadine and Montelukast HCL in Bulk and Pharmaceutical Dosage Form

Abstract

A Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and optimized for the simultaneous estimation of Fexofenadine and Montelukast in bulk and pharmaceutical dosage forms. The method was established by studying various chromatographic parameters to achieve optimal separation and accurate quantification of both drugs. The maximum absorbance for both drugs was found to be at 210 nm, with excellent peak purity. An injection volume of 10 µL was chosen, which resulted in good peak area and resolution. The Altima C18 column was selected for its ability to provide clear, distinct peaks. The mobile phase, consisting of Methanol: TEA Buffer pH 4.5: Acetonitrile (50:25:25), was optimized for optimal peak symmetry. The flow rate was maintained at 1.0 mL/min, ensuring satisfactory retention times and peak areas. The total run time was set to 7 minutes, with Fexofenadine and Montelukast eluting at 2.102 and 3.537 minutes, respectively. The method demonstrated excellent linearity over the concentration range of 5-25 mg/mL for Fexofenadine and 12.5-62.5 mg/mL for Montelukast. The method exhibited good recovery (98.0-102%) and precision, with relative standard deviations within acceptable limits. The method was validated for robustness and ruggedness, showing satisfactory results. This RP-HPLC method offers a reliable, efficient, and precise approach for the simultaneous determination of Fexofenadine and Montelukast in pharmaceutical formulations, ensuring its applicability for routine quality control and regulatory compliance.