A sensitive high‐performance liquid chromatographic assay for the cholecystokinin‐b antagonist, CI‐988, in human and monkey plasma

Abstract
A sensitive and specific high‐performance liquid chromatographic assay for the non‐peptide cholecystokinin subtype B receptor antagonist, CI‐988, in human and cynomolgus monkey plasma has been developed and validated. The method involves isolation of CI‐988 and internal standard by batch robotic solid phase extraction with a C18 cartridge, liquid chromatographic separation on a C18 column and quantitation by fluorescence detection. The human plasma assay is linear from 0.25 to 500 ng/mL for a 1.00‐mL plasma aliquot. Assay precision for CI‐988 based on human plasma quality control samples was within ±7.2% relative standard deviation with an accuracy of ±5.6% relative error. The monkey plasma assay is linear from 1.00 to 250 ng/mL for a 0.500‐mL plasma aliquot. Assay precision based on monkey plasma quality control samples was within ±11.0% relative standard deviation with an accuracy of ±2.6% relative error.