Accession Number : ADB093522

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

Descriptive Note : Annual rept. 1 Sep 83-31 Aug 84,

Corporate Author : CALIFORNIA UNIV SAN FRANCISCO SCHOOL OF PHARMACY

Personal Author(s) : Lin,E. T. ; Benet,L. Z. ; Upton,R. A. ; Gee,W. L.

Report Date : 29 OCT 1984

Pagination or Media Count : 43

Abstract : A high performance liquid chromatographic (HPLC) procedure for the analysis of pyridostigmine in plasma has been developed. Only 0.5 ml of plasma is required for the analysis. The clean-up procedure involves a protein precipitation step and a column elution step prior to separation by HPLC. The assay is quite sensitive, with a detection limit of 2 ng/ml for pyridostigmine bromide in plasma. Assay precision was evaluated from blind samples in the range of 0 - 50 ng/ml and the difference was 8 to 12%. Stability was also determined for pyridostigmine in plasma at -20 C and -80 C. The results showed no degradation for pyridostigmine at -80 C for up to two months. In a preliminary study with one human volunteer, the drug was detected up to 8 hours following oral doses of syrup solution of 0.4 to 0.9 mg/kg. This assay is suitable for pharmacokinetic studies involving pyridostigmine in human subjects.

Descriptors :   *BLOOD CHEMISTRY, *LIQUID CHROMATOGRAPHY, *BIOASSAY, *DRUGS, ELUTION, HUMANS, VOLUNTEERS, PRECIPITATION, PROTEINS, SAMPLING, DEGRADATION, PHARMACOKINETICS, BROMIDES, CARBAMATES, HYDROXYL RADICALS, METHYL RADICALS, PYRIDINES

Subject Categories : Biochemistry
      Pharmacology

Distribution Statement : APPROVED FOR PUBLIC RELEASE