Development of Analytical Methods for the Determination of Drug Substances in Biological Fluids.
Annual rept. 1 Oct 82-31 Aug 83,
CALIFORNIA UNIV SAN FRANCISCO SCHOOL OF PHARMACY
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WR6026 2HCl 6-methoxy-8-6-diethyl amino hexyl amino epidine dihydrochloride is a very effective antileishmanial drug in hamsters infected with L donovani. A high pressure liquid chromatographic HLPC procedure for the analysis of WR6026 in plasma has been developed. Only 0.5 mil of plasma is required for analysis. The clean-up procedure involves a protein precipitation step and a column elution stem prior to separation by HPLC. The assay is quite sensitive with a detection limit of less than 10 ngml of plasma. Assay precision has been evaluated and variability is less than 6. Accuracy was evaluated from blind samples in the range of 10-100 ngmL and the difference was 1.13 - 8.04. Stability was also determined for WR6026 in plasma frozen for up to three months. Human plsma samples were analyzed for WR6026 the drug could be detected up to 24 hours following a 60 mg oral dose. In a preliminary study with human volunteers, no mono-N-deethylated derivative of WR6026 was found in human plasma. This assay is suitable for pharmacokinetic studies involving WR6026 in human subjects.