Method Development and Validation of Fexofenadine and Montelukast in Pure and Pharmaceutical Formulation

This study aimed to Develope and validate a precise and reliable reverse phase high-performance liquid chromatographic (RP-HPLC) method for identification and quantification of fexofenadine hydrochloride and montelukast in both pure form and pharmaceutical formulations.

Chromatographic analysis was conducted at 248nm using a DAD detector on an Agilent RP C-18 column (5μm; 4.6 × 250mm ID) with a flow rate of 0.8ml/min. A methanol-0.05% formic acid mixture (40:60 v/v) served as the mobile phase. Method validation was performed in accordance with ICH guidelines assessing linearity, accuracy, precision, and robustness.

The developed method was applied to analyze both pure compounds and pharmaceutical formulations. Retention times were determined to be 4.523 for fexofenadine and 6.380 for montelukast. The method exhibited linearity across concentration ranges of 24-120μg/ml for fexofenadine and 2-10μg/ml for montelukast, with a correlation coefficient of 0.999. The relative standard deviation for six replicates was consistently below 2%.

The RP-HPLC method developed in this study demonstrated satisfactory linearity, accuracy, precision, and robustness, making it suitable for routine quantification and identification of these drugs in both pure form and pharmaceutical formulations.