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:

1984-10-29

Pagination or Media Count:

43.0

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 ngml for pyridostigmine bromide in plasma. Assay precision was evaluated from blind samples in the range of 0 - 50 ngml 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 mgkg. 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