Open J Pharma Sci
Objective: A successful attempt has been made to develop simple, accurate, economic and rapid methods for the estimation of Montelukast and Fexofenadine in tablet formulation by RP-HPLC and to validate the methods, as per the guidelines given by ICH requirements to assure that the method consistently meets the predetermined specifications and quality attributes.
Method: Separation of Montelukast and Fexofenadine successfully achieved on RP-HPLC with Thermo 2080 system, P4000 Quaternary pump, UV 6000 PDA detector, ARP-C18 (250 mm X 4.6 mm), 5? column or equivalent utilizing mobile phase composed of Acetonitrile: Phosphate buffer (pH2.8)in the ratio of 70:30 v/v as mobile phase at a flow rate of 1mL/min and the eluates was monitored at 245 nm.
Result: Chromatogram showed a peak at a retention time of 3.624 min and 5.178 min for Montelukast and Fexofenadine respectively. The method for simultaneous estimation was validated for system suitability, linearity, precision, accuracy; specificity, ruggedness, robustness; LOD and LOQ. Recovery of Montelukast and Fexofenadine were found to be in the range of 99.2% and 99.13% and showing linearity in the range of 10-50 ?g/ml. The S/N for LOD was found to be 2.96 and 2.78 and LOQ were found 9.96 and 9.78for estimation of Montelukast and Fexofenadine respectively.
Conclusion: The developed method was found to be accurate, precise, linear, specific and reproducible for the simultaneous determination of Fexofenadine and Montelukast in formulation. Developed method can be successfully applied for the quantitative determination of Montelukast and Fexofenadine in Bulk drug and Pharmaceutical dosage form.