Abstract
This study aimed to develop and validate an innovative reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of montelukast sodium (MNK) and ebastine (EBA) in tablet formulations. Utilizing a Shimadzu LC2010CHT system with a Phenomenex Luna C18 column, the mobile phase consisted of ammonium acetate buffer, acetonitrile, and methanol in a 12:55:33 ratio, with a flow rate of 1.0 mL/min and detection at 250 nm. Validation followed ICH guidelines, assessing linearity, accuracy, precision, robustness, and stability under various stress conditions. Both MNK and EBA showed excellent linearity within 16 to 24 μg/mL with correlation coefficients of 0.999. Accuracy was confirmed through recovery studies showing 98 to 102% mean recoveries. Precision was demonstrated with %RSD values below 2%. The method remained robust under slight variations in conditions, and stability studies indicated minimal degradation of both drugs. The developed RP-HPLC method proved rapid, precise, and robust for the simultaneous quantification of montelukast and ebastine in tablet formulations, demonstrating practicality and reliability for pharmaceutical quality control.
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