Tam, Yat Kong and Blasko, Andrei (2017) Mitigating the Effect of Surfactants in Sample Preparation of a Phospholipid Formulation for Impurities Analysis by Reversed-Phase Liquid Chromatography. LCGC North America, 35 (5). pp. 321-328. ISSN 1939-1889

Abstract

A surfactant-based diluent was used in sample preparation for reversed phase high performance liquid chromatography (HPLC) analysis of a drug product and its impurities in a phospholipid formulation. The use of didodecyl trimethylammonium bromide (DDAB) enabled a consistent, quantitative extraction of the analytes of interest from the lipid matrix in a much more aqueous, weaker solvent than was specified in a previously established method. Water was added as an antisolvent to precipitate the surfactant from the system to eliminate HPLC injection pressure spikes, thereby enabling large-volume injections and achieving a consistent, robust method for long-term use. This article describes both the method development and validation steps.

Item Type:	Article
Keywords:	extractions, formulation, surfactants, phospholipid, HPLC
Date Deposited:	04 Jul 2017 00:45
Last Modified:	04 Jul 2017 00:45
URI:	https://oak.novartis.com/id/eprint/31671