EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

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ISSN 2394-3211

Impact Factor: 7.065

ICV - 79.57

Abstract

RP HPLC METHOD DEVELOPMENT & VALIDATION OF MONTELUKAST & FEXOFENADINE IN PHARMACEUTICAL DOSAGE FORM

Swapnil B. Deshmukh*, Jayshri A. Patil, Umesh T. Jadhao and Sandip T. Thoke

ABSTRACT

A simple, accurate and precise RP-HPLC method was developed and validated for determination of Montelukast Sodium (MONT) and Fexofenadine hydrochloride (FEXO) in pharmaceutical dosage form. The chromatographic separation was achieved on (Cosmosil) C18 column (4.6mm x 250mm) as stationary phase with a mobile phase comprising of Acetonitrile: Water(0.1% with OPA) 70:30 adjust pH 3 at a flow rate of 1.0 mL/min, column at Ambient temperature and UV detection at 241 nm. The retention time of Montelukast Sodium and Fexofenadine hydrochloride were 5.3666 min and 6.8333 min respectively. The linearity were found to be in the range of 1-5 μg/mL and 12-60μg/ml for Montelukast Sodium and Fexofenadine hydrochloride with correlation coefficient greater than 0.999. The precision of the method was demonstrated with % RSD while the % recovery was found in between 99.69 -100.17%. The proposed methods were validated as per ICH guidelines and successfully applied for the determination of investigated drugs in tablets.

Keywords: Montelukast Sodium, Fexofenadine hydrochloride, RP-HPLC, validation.

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