Analysis of Unstable Degradation Impurities and their Quantification without Isolation using Multiple Linear Regression

Analysis of Unstable Degradation Impurities and their Quantification without Isolation using Multiple Linear Regression

John M. Campbell, Ph.D.
Investigator, GlaxoSmithKline
Philadelphia, PA, USA

This presentation discusses a novel methodology developed for calculating the relative response factors (RRFs) of two highly unstable degradation impurities without isolation using only HPLC-UV data. Subsequent correction of HPLC peak areas with the experimentally-determined RRFs allowed for accurate quantification of the degradants and demonstrated mass balance in forced degradation samples.