Determination of oseltamivir quality by colorimetric and liquid chromatographic methods

Emerg Infect Dis. 2008 Apr;14(4):552-6. doi: 10.3201/eid1404.061199.

Abstract

We developed a colorimetric and chromatographic assay for oseltamivir to assess the authenticity of Tamiflu (F. Hoffmann-La Roche Ltd., Basel, Switzerland) because of a growing concern about counterfeit oseltamivir. The colorimetric assay is quantitative and relies on an extractable colored ion-pair complex of oseltamivir with Congo red or bromochlorophenol blue. The reverse-phase chromatographic assay uses an alkaline mobile phase with UV detection. Both methods were evaluated for variability and selectivity and subsequently applied to batches of oseltamivir products acquired through the Internet. The Congo red test showed greater assay sensitivity, linearity, and accuracy. Colorimetric and chromatographic analysis showed all batches of oseltamivir product were within +/-15% of the stated amount of active ingredient.

Publication types

  • Comparative Study
  • Validation Study

MeSH terms

  • Antiviral Agents / chemistry
  • Antiviral Agents / standards*
  • Bromphenol Blue / analogs & derivatives
  • Chromatography, High Pressure Liquid*
  • Colorimetry*
  • Coloring Agents
  • Congo Red
  • Molecular Structure
  • Oseltamivir / chemistry
  • Oseltamivir / standards*
  • Quality Control

Substances

  • Antiviral Agents
  • Coloring Agents
  • Bromphenol Blue
  • Oseltamivir
  • bromochlorophenol blue
  • Congo Red