Novel combination of Fexofenadine hydrochloride (FEXO) and Montelukast Sodium (MONT) 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 297.10(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 12‐60 μg/ml (R2 = 0.9993) for Fexofenadine hydrochloride and 1‐5 μg/ml (R2 = 0.9988) for Montelukast sodium. The average percentage recovery of Fexofenadine hydrochloride and Montelukast sodium combination was found to be 100.20% and 99.28% respectively. The LODs for Fexofenadine hydrochloride and Montelukast sodium were 2.7862 μg/ml and 3.0657 μg/ml and LOQs were found to be 8.4432 μg/ml and 9.2902 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.
Loading....