Abstract

Rp-HPLC METHOD DEVELOPMENT AND VALIDATION: SIMULTANEOUS ESTIMATION OF FEXOFENADINE HYDROCHLORIDE, MONTELUKAST SODIUM AND ACEBROPHYLLINE IN TABLET DOSAGE FORM

Dr. Gayatri Barabde*, Aarti Babu Kokate and Priyanka Pataskar

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Abstract

Background: A simple, specific, linear, precise and accurate reverse phase liquid chromatographic method was developed for the simultaneous determination of fexofenadine HCl, Montelukast Na and Acebrophylline in tablet dosage forms. The chromatographic separation was performed using Waters sperisorb ODS 1 Column (250 mm x 4.6 mm, 5 μm particle size). Mobile phase composed of 0.1% Triethylamine and acetonitrile and a flow rate of 1 ml/minute is monitored with injection volume of 5 μl. Detection was carried out at 235 nm. The method was validated as per ICH guidelines. The retention time for fexofenadine HCl, Montelukast Na, Ambroxol and Theophylline are observed as 6.3, 5.5 and 7.2 & 2.6 minutes respectively. Linearity range was observed in concentration of 60.03 – 180.08 μg/ml for fexofenadine HCl, 5.14 – 15.42 μg/ml for Montelukast Na and 100.13 – 300.38 μg/ml for Acebrophylline. The percentage recoveries of fexofenadine HCl, Montelukast Na and Acebrophylline are 99.25%, 101.20 and 99.08% respectively. The correlation coefficients for all the components are close to 1. The proposed method was validated and successfully applied to the estimation of fexofenadine HCl, Montelukast Na and Acebrophylline in pharmaceutical dosage forms.

Keywords: Fexofenadine HCl, Montelukast Na, Acebrophylline, method development, Validation.