Development and validation of RP-HPLC method for simultaneous estimation of Montelukast Sodium and Fexofenadine hydrochloride in combined dosage form

A simple, fast and precise reverse phase high performance liquid chromatographic method has been developed for the simultaneous determination of Montelukast Sodium (MONT) and Fexofenadine hydrochloride (FEXO). The chromatographic separation was achieved on X-bridge C18 column (250 mm × 4.6 mm, 5 μm) as stationary phase with a mobile phase comprising of 50 mM Sodium acetate buffer:acetonitrile:methanol (25:35:40) adjust pH 8.2 with 5% o-phosphoric acid at a flow rate of 1.0 mL/min, column temperature of 40 ± 2 °C and UV detection at 210 nm. The retention time of Montelukast Sodium and Fexofenadine hydrochloride were 3.43 min, and 8.22 min respectively. The linearity were found to be in the range of 12.5-37.5 μg/mL and 150-450 μg/mL for Montelukast Sodium and Fexofenadine hydrochloride with correlation coefficient greater than 0.999. The proposed methods were validated as per ICH guidelines and successfully applied for the determination of investigated drugs in tablets.