ABSTRACT
A novel, simple, accurate, sensitive and reproducible first order derivative spectroscopic method was developed and validated for the estimation of Ebastine and Montelukast Sodium in combined dosage form. The method obeys Beer’s Law in concentration ranges of 7.5-17.5 µg/ml for Ebastine and Montelukast sodium both. The method was validated for linearity, accuracy and precision as per ICH guidelines. The zero crossing point for Ebastine and Montelukast Sodium was 231.73 nm and 256.30 nm respectively in methanol. The LOD and LOQ value were found to be 0.29 µg/ml and 0.87 µg/ml for Ebastine, 2.44 µg/ml and 7.39 µg/ml for Montelukast sodium respectively. The accuracy of the method was assessed by recovery studies was found to be 99.91 ± 0.080 and 99.47 ± 0.073 for Ebastine and Montelukast sodium respectively. The developed and validated method was successfully used for the quantitative analysis of commercially available dosage forms. The developed method further can be useful for dissolution study and bio analytical study for these drugs in combinations. (EBAST-M).
