Green Michael D, Nettey Henry, Wirtz Robert A
Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
Emerg Infect Dis. 2008 Apr;14(4):552-6. doi: 10.3201/eid1404.061199.
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.
由于对假冒奥司他韦的担忧日益增加，我们开发了一种用于奥司他韦的比色和色谱分析方法，以评估泰诺福韦（瑞士巴塞尔的F. Hoffmann-La Roche Ltd.）的真伪。比色分析是定量的，依赖于奥司他韦与刚果红或溴氯酚蓝形成的可萃取有色离子对络合物。反相色谱分析使用碱性流动相并进行紫外检测。对这两种方法的变异性和选择性进行了评估，随后应用于通过互联网购得的奥司他韦产品批次。刚果红试验显示出更高的分析灵敏度、线性和准确性。比色和色谱分析表明，所有批次的奥司他韦产品中活性成分的含量在规定量的±15%范围内。
