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A Stability Indicating Hplc Method for the Determination of Fluvoxamine in Pharmaceutical Dosage Forms



Souri E1 ; Donyayi H1 ; Ahmadkhaniha R2 ; Tehrani MB1
Authors
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Authors Affiliations
  1. 1. Department of Medicinal Chemistry, School of Pharmacy and Drug Design and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Department of Human Ecology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran

Source: Iranian Journal of Pharmaceutical Research Published:2015

Abstract

Fluvoxamine maleate is a selective serotonin reuptake inhibitor, which is used for the treatment of different types of depressive disorders. In the present study, a stability indicating HPLC method was developed and validated for the determination of fluvoxamine maleate. The chromatographic separation was carried out using a Nova-Pak CN column and a mixture of K2HPO4 50 mM (pH 7.0) and acetonitrile (60:40, v/v) as the mobile phase. Target compounds were detected using a UV detector set at 235 nm. The developed method was linear over the concentration range of 1-80 μg/ml with acceptable precision (CV values<2.0%) and accuracy (error values<1.6%). The degradation studies showed that fluvoxamine maleate is relatively unstable under acidic, basic and oxidative conditions and also when exposed to UV radiation. On the other hand, the bulk powder of fluvoxamine maleate was relatively stable when exposed to visible light or heat. The proposed method was successfully applied for the determination of active ingredient of fluvoxamine dosage form without any interference from tablet excipients. © 2015 by School of Pharmacy Shaheed Beheshti University of Medical Sciences and Health Services.