Development of Analytical Methods for the Determination of Drug Substances in Biological Fluids.
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.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 29, 1984
- Accession Number
- ADB093522
Entities
People
- E. T. Lin
- L. Z. Benet
- R. A. Upton
- W. L. Gee
Organizations
- University of California, San Francisco