DEVELOPMENT OF VALIDATED HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF FEXOFENADINE HYDROCHLORIDE AND MONTELUKAST SODIUM IN TABLET DOSAGE FORM

A simple, fast and precise reverse phase high performance liquid chromatographic method has been developed for the simultaneous determination of Fexofenadine hydrochloride (FEXO) and Montelukast Sodium (MONT). Efficient chromatographic separation was achieved on phenomenex C18 column (150mm x 4.6 mm, 5 mu m) as stationary phase with a mobile phase comprising of 0.5% Orthophosphoric acid pH adjusted to 6 (tri ethyl amine): Acetonitrile(40: 60 v/v) at a flow rate of 1.0mL min-1, column temperature of 25 degrees C and UV detection at 240 nm. The retention time of and Fexofenadine hydrochloride and Montelukast Sodium were 2.7 min, and 4 min respectively. The linearity were found to be in the range of 72-120 mu g/ml and 6-10 mu g/ml Fexofenadine Hydrochloride and Montelukast Sodium respectively with correlation co efficient of 0.999. The proposed method was validated for linearity, accuracy, precision, sensitivity. All validation parameters were within the acceptable range. The developed method was successfully applied to estimate the amount of Fexofenadine hydrochloride and Montelukast Sodium in combined dosage forms.