Accession Number : ADB113975

Title :   Development of Analytical Methods for the Determination of Drug Substances in Biological Fluids.

Descriptive Note : Annual rept. 1 Sep 84-31 Aug 85,

Corporate Author : CALIFORNIA UNIV SAN FRANCISCO SCHOOL OF PHARMACY

Personal Author(s) : Lin, Emil T. ; Benet, Leslie Z. ; Upton, Robert A. ; Gee, Winnie L.

Report Date : 13 DEC 1985

Pagination or Media Count : 35

Abstract : Methods available to quantitate halofantrine, an antimalarial drug with demonstrated activity against Plasmodium falciparum, in blood and plasma are limited. We report the development of a simple and rapid HPLC assay for the analysis of 0.5 ml blood and plasma specimens. The method detection limit is 1 ng/ml for both halofantrine (WR 171,669) and its putative metabolite (WR 178,460). The method's principal techniques include sample cleanup by protein precipitation and by a column elution step, precautions against loss of drug because of absorption to glass, and fluorescence detection. The method proved adequate in tests of linearity, recovery, precision, and accuracy. Drug stability tests of specimens stored at -20C and 80C indicated the necessity of storage at 80C. Routine analysis of human and animal blood plasma samples were satisfactory performed. Keywords: Halofantrine (WR 171,669), Putative Metabolite (WR 178,460); Blood; Blood Plasma.

Descriptors :   *ANTIMALARIALS, *BIOASSAY, *LIQUID CHROMATOGRAPHY, *BODY FLUIDS, ANTIMALARIALS, LABORATORY ANIMALS, BLOOD PLASMA, DETECTION, DETERMINATION, DRUGS, ELUTION, FLUORESCENCE, HUMANS, LIMITATIONS, METABOLITES, PLASMODIUM FALCIPARUM, PRECIPITATION, PROTEINS, SAMPLING, TEST METHODS.

Subject Categories : Medicine and Medical Research
      Biochemistry

Distribution Statement : APPROVED FOR PUBLIC RELEASE