Polysorbate 80 UV/vis spectral and chromatographic characteristics – defining boundary conditions for use of the surfactant in dissolution analysis

详细信息    查看全文

• 作者：W. Peter Wuelfing ; Kathryn Kosuda ; Allen C. Templeton ; Amy Harman ; Mark D. Mowery and Robert A. Reed
• 关键词：Polysorbate 80 ; UV/vis spectra ; Reversed-phase chromatography ; Dissolution analysis ; Pharmaceutical analysis ; Chromatographic interference
• 刊名：Journal of Pharmaceutical and Biomedical Analysis
• 出版年：2006
• 出版时间：7 June 2006
• 年：2006
• 卷：41
• 期：3
• 页码：774-782
• 全文大小：529 K

文摘

Polysorbate 80 is used in the pharmaceutical industry as an additive to enhance the solubility of non-polar compounds in formulation design and during dissolution analysis. In this paper we present the spectroscopic and chromatographic characteristics for a series of commercially available sources of this non-ionic surfactant. The large UV/vis absorbance and broad chromatographic elution of Polysorbate 80 often makes it difficult to accurately quantitate pharmaceutically active compounds in solutions where the surfactant is present. Boundary conditions have been established where analytical interferences can be avoided in spectrophotometric analysis by choice of analysis wavelength and solution concentrations. Chromatographic method development is also presented enabling the removal of Polysorbate interference in instances where spectroscopic interference is too great.