Determination of Oseltamivir Quality by Colorimetric and Liquid Chromatographic Methods

Details

• Alternative Title:
  Emerg Infect Dis
• Personal Author:
  Green, Michael D. ; Nettey, Henry ; Wirtz, Robert A.
• Description:
  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.
• Subjects:
  Antiviral Agents Bromphenol Blue Chromatography, High Pressure Liquid Colorimetry Coloring Agents Congo Red Molecular Structure Quality Control Research
• Source:
  Emerg Infect Dis. 14(4):552-556.
• Document Type:
  Journal Article
• Volume:
  14
• Issue:
  4
• Collection(s):
  Emerging Infectious Diseases
• Main Document Checksum:
  urn:sha256:2e7c59fc7d13488813abd408661ef87613c9221ca12f7d7b6a829c0223410118
• Download URL:
  https://stacks.cdc.gov/view/cdc/3165/cdc_3165_DS1.pdf
• File Type:
  [PDF - 203.10 KB ]