Analysis of Investigational Drugs in Biological Fluids - Method Development and Routine Assay.
Annual rept. no. 1, 15 Mar 86-14 Mar 87,
CALIFORNIA UNIV SAN FRANCISCO SCHOOL OF PHARMACY
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This report describes the status of method developement and routine analytical work. The purpose of this work is to develop and routinely use analytical methods for the determination of the concentration in biological specimens of investigational drugs in support of pharmacokinetic and bioavailability studies undertaken for the purpose of new drug development for the US military establishment. Accepted scientific procedures including normal and reversed phase high-performance liquid chromatographic methods, post column derivatization, and protein precipitation and cartridge elution sample clean up procedures were employed in development and routine work. Six methodologies for the assay of samples for WR 2721 in plasma, WR 3689 in plasma, pyridostigmine in urine, mefloquine in plasma, physostigmine in plasma and WR 6026 in blood are currently under development, three routine analysesfor determination of the concentrations of pyridostigmine in urine, WR 6026 in plasma, and halofantrine in plasma have been performed in support of bioavailability and pharmacokinetic studies, and routine analyses for mefloquine in plasma and pyridostigmine in plasma are in progress in support of other studies.