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  • Chem Sci Trans., 2013, 2(3),  pp 889-899  

    DOI:10.7598/cst2013.361

    Research Article

    Development and Validation of RP-HPLC Method for Estimation of Montelukast Sodium and Fexofenadine Hydrochloride in Pharmaceutical Preparations

  • M. KALYANKAR TUKARAM*, R. WALE RISHA and B. KAKDE RAJENDRA
  • School of Pharmacy, Swami Ramanand Teerth Marathwada University, Nanded-431606 (MS) India
    University Deptt. of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University, Campus, Nagpur-440033, MS, India
  • Abstract

    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.

    Keywords

    Montelukast sodium, Fexofenadine hydrochloride, Recovery, Liquid chromatography, Validation

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