Analytical Method Development and Validation for Simultaneous Estimation of Montelukast and Ebastine by HPLC

A RP-HPLC method was developed and validated for simultaneous estimation of montelukast and ebastine in bulk as well as in tablet formulation according to ICH guidelines. The chromatographic separations of drugs were achieved on Younglin (S.K) isocratic system with Lichrocart C18 column (4.6 mm×250 mm, 5μm). The mobile phase consisted by methanol and water (80: 20) at pH 3 adjusted by ortho phosphoric acid. The flow rate was adjusted to 1 ml/min and UV detection was carried out at 268 nm. The retention time for montelukast and ebastine were found to be 6.56 and 2.95 min respectively. The detector was showed linear responses over the concentration range 5 – 25 μg/mL for both drugs by showing a good correlation coefficient of 0.999. This proposed method is highly sensitive, precise and accurate which reduces cost of analysis; hence recommended for routine quality analysis in laboratories.