New LC-MS methodology: Accurate, precise and fully robust quantitative analysis of Tween 20 & Tween 80 in drug product and drug substance (full validation data)
Nick Callan
SGS Life Science Services, UK
: J Pharm Drug Deliv Res
Abstract
Tween 20 and Tween 80 are non-ionic surfactants that contain a fatty acid ester moiety and polyoxyethylene chain. They are typically used in the formulation of biopharmaceuticals to prevent surface adsorption and protein aggregation. Tween compounds do not contain a UV chromophore and analysis has typically been carried out using Evaporative Light Scattering Detector (ELSD) and High Performance Liquid Chromatography (HPLC). Improved accuracy and precision, along with higher selectivity, has been achieved using LC-MS. Instrument carryover and contamination issues were first encountered and resolved. New LC-MS methods have been developed at SGS for the quantitative analysis of excipient Tween 20 and Tween 80 in Drug Substance and Drug Product with typical mean recoveries of between 95% to 105% and repeatability of independently prepared sample replicates of ≤5%. The robustness of the methods has been tested with different analysts, days, columns, mobile phase preparations, instruments and client products with similar results. The methods have been adapted for the residual clearance analysis of Tween 20, Tween 80 and also Triton X-100 in Drug Substance and earlier In-Process samples.
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