Validation of Assay for Simultaneous Estimation of Ebastine and Montelukast in Tablet Dosage Forms by RP-HPLC Method

Abstract

A simple, accurate, precise, economical method was developed for the simultaneous estimation of the Ebastine and Montelukast in tablet dosage form by the RP-HPLC method. The chromatogram was run through Kromosil (250mm x 4.6 mm, 5m.) The mobile phase containing potassium dihydrogen phosphate buffer and Acetonitrile was taken in the ratio 60:40 was pumped through the column at a flow rate of 1ml/min. The pH was adjusted to 4.8 with Orthophosphoric acid. A buffer used in this method was potassium dihydrogen phosphate solution. The temperature was maintained at 30°C. The optimized wavelength for Ebastine and Montelukast was 244nm. The retention time of Ebastine and Montelukast were found to be 2.447 min and 3.436 min respectively. With the optimized chromatographic conditions, the drug was linear in the concentration range of 0 -150 μg/ ml. The correlation coefficient was found to be 0.999. The average percentage assay in the formulation was found to be 99.05% and 99.20% for Ebastine and Montelukast respectively. % Recovery for Ebastine and Montelukast was found to be 99.93% and 99.69% respectively. %RSD for repeatability was found to be 0.2 respectively. LOD, LOQ values are obtained from regression equations of Ebastine and Montelukast were 0.11ppm, 0.33ppm and 0.14ppm, 0.43ppm respectively. Regression equation of Ebastine is y = 19263x+1149, and y = 19946x+1095 of Montelukast. Hence the suggested RP-HPLC method can be used for routine analysis of Ebastine and Montelukast in API and Pharmaceutical dosage form.