Method Development and Validation for Simultaneous Estimation of Montelukast and Fexofenadine in Pharmaceutical Dosage Form by HPLC Method

Objective of the present work was to develop a simple and precise HPLC method for montelukast sodium (MON) and fexofenadine hydrochloride (FEX). The combination is used as anti-asthmatic, anti-allergic and is available in tablet dosage form. HPLC separation was achieved with a hypersil ODS-C18 (5 μ, 250 mm x 4.6 mm, i.d.) as a stationary phase and methanol: acetonitrile: 1% trifluoroacetic acid (80:10:10 v/v/v) as eluent, at a flow rate of 1.0 mL/min, UV detection was performed at 210 nm. The retention time of montelukast sodium and fexofenadine hydrochloride were found to be 5.1 and 3.7 min respectively. Results of analysis were validated by recovery studies. Result of studies showed that the proposed RP-HPLC method is simple, rapid, accurate and precise which can be used for the routine determination of montelukast sodium and fexofenadine hydrochloride in bulk and its pharmaceutical dosage form.