Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2012 Vol: 4 Issue: 11

A RP-HPLC method development and validation for the estimation of aliskiren hemifumarate in bulk and pharmaceutical dosage forms

Abstract

A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for rapid assay of Aliskiren Hemifumarate in pharmaceutical dosage form. Isocratic elution at a flow rate of 1.0 mL min -1 was employed on a Symmetry C18 column at ambient temperature. The mobile phase consisted of acetonitrile: phosphate buffer 60:40 (v/v) and the detection wavelength was at 234 nm. Linearity was observed in concentration range of 50-175 μg/mL. The retention time for Aliskiren was 2.28 min. The method was validated as per the ICH guidelines. The proposed method can be successfully applied for the estimation of Aliskiren in pharmaceutical dosage forms.

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