Simultaneous Determination of Montelukast Sodium and Fexofenadine Hydrochloride in Combined Dosage Form by Using RP-HPLC Method

A simple, accurate, economical and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the determination of montelukast sodium and fexofenadine hydrochloride in bulk and pharmaceutical formulations. The separation was achieved on a phenomenex C column (150 × 4.6 mm i.d, particle size of 5μ) using a mixture of 0.1M potassium dihydrogen 18 orthophosphate buffer (pH 5.0) and methanol in the ratio of 60:40 v/v as mobile phase in an isocratic elution mode, at a flow rate of 1 ml/min. The detection was monitored at 220 nm. The retention time of montelukast sodium and fexofenadine hydrochloride was found to be around 2.17 ± 0.12 min and 6.24 ± 0.14 min respectively. Excellent linearity range was found between 5-15 μg/ml for montelukast sodium and 10-100 μg/ml for fexofenadine hydrochloride. The method was validated with respect to linearity, robustness, precision and accuracy and was successfully applied for the simultaneous determination of montelukast sodium and fexofenadine hydrochloride from the combined dosage formulation.