Analysis of Investigational Drugs in Biological Fluids Method Development and Routine Assay
Annual rept. 15 Mar 1987-14 Mar 1988
CALIFORNIA UNIV SAN FRANCISCO SCHOOL OF PHARMACY
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The purpose of work under this contract 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. Methodologies for six drugs for the assay of samples for WR 2721 in plasma, WR 3689 in plasma, pyridostigmine in urine, mefloquine in plasma, physostigmine in plasma and WR6026 in blood were under development, two routine analyses for determination of the concentrations of mefloquine in plasma and pyridostigmine in plasma and urine have been performed in support of bioavailability and pharmacokinetics studies, and routine analyses for pyridostigmine in dog plasma and pyridostigmine in human plasma are in progress in support of other studies. Significant progress has been made in meeting the objectives of the contract.