Development of Analytical Methods for the Determination of Drug Substances in Biological Fluids.
Annual rept. 1 Sep 83-31 Aug 84,
CALIFORNIA UNIV SAN FRANCISCO SCHOOL OF PHARMACY
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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.