Analysis of Polysorbate 80 in IgG Aqueous Solution by Online SPE Using Shim-pack MAYI Column – Part 1

Introduction

Various analyses are required in the evaluation of drugs. When analyzing samples that contain macromolecular proteins at high concentrations by reversed phase HPLC, degradation of the column packing is a concern when using a typical ODS column, therefore requiring prior removal of proteins. As the Shim-pack MAYI series, with its packing pore outer surface coated with a hydrophilic polymer, offers a line-up of online SPE columns that can quickly eliminate proteins, when combined with a column switching HPLC, a variety of components can be analyzed in a seamless flow from deproteinization to analysis. Examples of applications related to analysis of drugs in plasma and serum using the MAYI series have previously been reported in Application News No. L285, 286, 293, 305, 307, 315 and 327. By using the Co- Sense for BA bio-sample analysis system, even higher sensitivity, higher precision measurement can be achieved. Here, we introduce an example of analysis of the polysorbate 80 surfactant, widely used as an additive to prevent protein aggregation and adsorption, and to increase protein solubility in a protein formulation.

April 8, 2015 GMT