Mitigating the Effect of Surfactants in Sample Preparation of a Phospholipid Formulation for Impurities Analysis by Reversed-Phase Liquid Chromatography
May 01, 2017
A surfactant based diluent was used in sample preparation for reversed phase HPLC analysis of a drug product and its impurities in a phospholipid formulation. The use of the didodecyl trimethylammonium bromide (DDAB) enabled a consistent, quantitative extraction of the analytes of interest from the lipid matrix in a much more aqueous, weak solvent. Water was added as an anti-solvent to precipitate out the surfactant from the system to eliminate HPLC injection pressure spikes, enabling large volume injections and achieving a consistent, robust method for long term use. Method development and validation steps are described.