Bioanalytics – Chemical
2019 PharmSci 360
A total of 11 Bile Acids (CA, tCA, gCA, CDCA, gCDCA, tCDCA, DCA, gDCA, tDCA, LCA, UDCA) were validated in charcoal stripped human plasma following the current FDA regulatory guidelines. The analysis is performed on a Thermo Fisher Scientific QE using full scan analysis and HR-AM for quantiation. In the development the challenges of endogenous interference in the stripped matrix and in authentic matrix were addressed in order to confirm any matrix effects from an authentic sample was being accurately quantitated against the curve fortified in surrogate matrix. Other challenges included the separation of the 11 bile acids from their isomers and other common species present in the authentic human plasma.