Stability Indicating Method Development and Validation of Fexofenadine and Montelukast in Pure and Pharmaceutical Formulation

Objective: The primary objective of this work is to develop and validate a simple, reliable, and sensitive technique for the analysis of fexofenadine hydrochloride and montelukast and to use the proposed method for the analysis of the drugs in pharmaceutical dosage forms. Materials and Method: Chromatographic separation of fexofenadine hydrochloride and montelukast was carried out using Agilent RP C-18 (5μm; 4.6 x 250 mm ID) column having mobile phase Methanol and 0.05%Formic acid in a ratio of 40:60v/v with 0.8ml/min flow rate. Wavelength used throughout study was 248nm with DAD detector at 26oC. Result and Discussion: Newly developed method and forced degradation study was carried out as per the ICH guidelines. The proposed method effectively identifies and quantify the drug in the formulation. The linearity of this method was found within the range of 24-120μg/ml and 2-10μg/ml for fexofenadine and montelukast respectively. For six replicates, the relative standard deviation is always less than 2%.In forced degradation study the drugs shows the maximum degradation in acidic condition. Conclusion: From the study results of recovery, robustness, accuracy, precision, linearity and specificity of the proposed stability-indicating RP-HPLC technique for fexofenadine and montelukast is suitable for precise identification and quantification in combined formulation and can be used in routine analysis.