Stability indicating method development and validation for simultaneous estimation of ebastine and montelukast in pharmaceutical dosage form

Abstract

A rapid and sensitive method with UV detection (244nm) was developed for the simultaneous estimation of Ebastine

and Montelukast in pharmaceutical dosage form. Using the column Discovery C8 250mm x 4.6 mm, 5 with mobile

phase containing buffer and acetonitrile taken in the ratio 62:38 was pumped through column at a flow rate of

1.2ml/min and temperature was maintained at 300 c.Retention time of Ebastine and Montelukast were found 2.526

min and 3.249 min, %RSD were and found to be 0.5 and 0.8 respectively and %Assay was obtained as 98.89% and

99.40% respectively. LOD, LOQ values are obtained from regression equations of Ebastine and Montelukast were

0.04ppm, 0.13ppm and 0.29ppm, 0.88ppm respectively. Regression equation of Ebastine is y = 14905x+2045, and y

= 12898x+24873 Of Montelukast.