Analysis of Pemoline in Serum by High Performance Liquid Chromatography

Abstract

The analysis of pemoline (2-imino-5-phenyl-4-oxazolidine) by a rapid, sensitive and specific high performance liquid chromatographic assay using UV detection is described. Only 100 .mu.l of plasma or serum is required. Analytical recoveries of 88% for pemoline and 93% for the internal standard (4-methylprimidone) are obtained by this procedure. Between-day precision studies of serum controls containing 10.0, 2.0 and 0.5 mg pemoline/l produce coefficients of variation of 6.2, 9.4 and 16.2%, respectively. A clinical study of 28 children treated with pemoline demonstrated a linear relationship between drug dose and serum concentrations with an apparent therapeutic range falling between 1.7-7.0 mg/l. These serum concentrations were achieved at drug dosages between 37.5-112.5 mg/day.