Novel combination of Fexofenadine hydrochloride (FEXO) and Montelukast Sodium (MTKT) is available as tablet dosage form in the ratio of 12:1 and no spectrophotometric method has been reported yet. The present research work aims to develop a simple, sensitive, accurate and reproducible method for the simultaneous estimation of both drugs by the first derivative spectrophotometric method, using methanol: water (20:80) as a solvent. The Method was performed at 212.60(zero crossing point of montelukast sodium) and 340.60(zero crossing point of fexofenadine hydrochloride) for Fexofenadine hydrochloride and Montelukast sodium respectively. The regression analysis data for the calibration plot showed good linear relationship in the concentration range of 4‐24 μg/ml (R2 = 0.9999) for Fexofenadine hydrochloride and 4‐24 μg/ml (R2 = 0.998) for Montelukast sodium. The average percentage recovery of Fexofenadine hydrochloride and Montelukast sodium combination was found to be 103.00% and 103.47% respectively. The LODs for Fexofenadine hydrochloride and Montelukast sodium were 1.895 μg/ml and 2.7055 μg/ml and LOQs were found to be 5.743 μg/ml and 8.198 μg/ml respectively. Statistical analysis proves that the method is reproducible and selective for the simultaneous determination of Fexofenadine hydrochloride and Montelukast sodium. The Results were found to be within acceptance criteria according to ICH Q2 R1 guidelines.
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