Determination and characterization of polysorbates using HPLC with charged aerosol detectors

ANYL 39

SungAe Suhr Park, spark@amgen.com1, Songpon Deechongkit2, and Bruce A. Kerwin, bkerwin@amgen.com1. (1) Pharmaceutics, Amgen Inc, One Amgen Center Drive, MS 8-1-C, Thousand Oaks, CA 91320, (2) Department of Pharmaceutics, Amgen Inc, One Amgen Center Drive, MS 8-1-C, Thousand Oaks, CA 91320
Polysorbates 20 and 80 are widely used in the biotechnology industry, however a rapid chromatographic method for evaluating their stability is not available. We developed a method to evaluate stability of polysorbates in protein formulations. A Phenomenex column was utilized with a flow-rate that increased from 0.6 mL/min to 1.2 mL/min and a mobile phase gradient from 2% acetic acid in water to 100 % acetonitrile. A charged aerosol detector (CAD) was used for detection of the polysorbates and a mass spectrometry was utilized for on-line mass characterization. Stability of polysorbates 20 and 80 from different manufacturers and sources were compared under acidic, basic, and thermal conditions. The combination of RP-HPLC with CAD detection yielded clear separation and identification of polysorbates 20 and 80. This method is sensitive, robust, and useful for monitoring the stability of the polysorbates in protein formulations.

 

General Papers
7:00 PM-9:00 PM, Sunday, 10 September 2006 Moscone Center -- Hall D, Poster

Division of Analytical Chemistry

The 232nd ACS National Meeting, San Francisco, CA, September 10-14, 2006