SIMULTANEOUS ESTIMATION OF METHOD DEVELOPMENT AND VALIDATION OF MONTELUKAST AND FEXOFENADINE BY USING REVERSE PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD

A simple, specific, precise and accurate Stability indicating RP-HPLC method for simultaneous estimation of Montelukast and Fexofenadine in its pure and pharmaceutical dosage form has been developed and validated as per ICH Guidelines. The separation was achieved by Phenomenex Gemini ODS C18 (4.6mm×250mm) 5µm column and Acetonitrile: Methanol: Water (55:25:20% v/v) used as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 229 nm. Retention time of Montelukast and Fexofenadine were found to be 2.157 min and 3.631 min respectively. The method has been validated for linearity, accuracy, precision, robustness, LOD and LOQ. Linearity observed for Montelukast 10 – 30μg/ml and for Fexofenadine 6 - 14μg/ml. Developed method was found to be accurate, precise and simple, specific for simultaneous estimation of Montelukast and Fexofenadine in pure form and their Combined Pharmaceutical Dosage Form. The precision results are not more than 2%. The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial combined dosage form.