Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF FEXOFENADINE HCL AND MONTELUKAST SODIUM BY RP-HPLC IN PURE AND COMBINED TABLET DOSAGE FORM

Yakkala Lakshmi Manasa*, Naidu Srinivasa Rao, Meghana Reddy.Regalla

ABSTRACT

A simple, accurate, economical and precise reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for the simultaneous determination of Fexofenadine hydrochloride and Montelukast Sodium. The separation was achieved on an X-Terra C18 column (100 x 4.6 mm, 5 μm) as stationary phase with a mobile phase comprising of 0.1% Triethylamine: Acetonitrile (30:70) in an isocratic mode, at a flow rate of 0.8 ml/min. The detection was monitored at 220 nm. The retention time of Fexofenadine hydrochloride and Montelukast Sodium were 1.425min and 3.364 min respectively. The linearity was found to be in the range of 35-105 μg/ml and 2.9-8.7 μg/ml for Fexofenadine hydrochloride and Montelukast Sodium respectively with correlation coefficient of 0.999. The proposed method was validated according to ICH guidelines for parameters like linearity, accuracy, precision and specificity. All validation parameters were within the acceptable range. The developed method was successfully applied for the estimation of Fexofenadine hydrochloride and Montelukast Sodium in pure and pharmaceutical dosage form.

Keywords: Fexofenadine hydrochloride, Montelukast Sodium, RP-HPLC, Validation, Simultaneous estimation, ICH guidelines.