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Abstract

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF EBASTINE AND MONTELUKAST BY RP-HPLC

Mangamma Kuna*, Christina Emette Jaldi, Preethi Undru and Prasanna S.B.R

ABSTRACT

An accurate, precise, simple method for the simultaneous estimation of Ebastine and Montelukast in a solid dosage form was developed. The Chromatogram was run through Altima 250mm x 4.6 mm, 5μm. Buffer and Acetonitrile which is used as a mobile phase was taken in the ratio of 45:55 was pumped through column at a flow rate of 1ml/min. 0.1% Ortho phosphoric acid (OPA) solution is the buffer used in this method. The temperature was maintained at 30°C and the Optimized wavelength for Ebastine and Montelukast was 252 nm. The retention time of Ebastine was found to be 2.447 and that of Montelukast was 3.436 minutes respectively. Percent relative standard deviation (%RSD) of Ebastine and Montelukast was found to be within the acceptance (<2.0%). Percent assay was obtained as 99.05% and 99.75% for Ebastine and Montelukast respectively. Limit of detection and Limit of quantification obtained from regression equations of Ebastine and Montelukast were found to be 4ppm, 3ppm, and 12ppm, 8ppm respectively. Regression equation of Ebastine is y = 19263x+1150, and y = 19946x+1095 Of Montelukast.

Keywords: Ebastine, Montelukast, HPLC, Orthophosphoric acid, Acetonitrile.


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