SIMULTANEOUS ESTIMATION OF MONTELUKAST AND DOXOFYLLINE BY USING REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY IN API AND MARKETED FORMULATION

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Montelukast and Doxofylline, in its pure form as well as in tablet dosage form. Chromatography was carried out on X bridge C18 (4.6×150mm) 5µcolumn using a mixture of Methanol: Phosphate Buffer pH3 (60:40v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 260nm. The retention time of the Montelukast and Doxofylline was 2.6, 3.8±0.02min respectively. The method produce linear responses in the concentration range of 5-25µg/ml of Montelukast and 20-100µg/ml of Doxofylline respectively. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords: Montelukast and Doxofylline, RP-HPLC, Validation, Precision.