Wm. Maniara et Ml. Powell, DETERMINATION OF THE RIFAMYCIN-RELATED HYPOLIPIDEMIC DRUG CGP-43371 IN HUMAN FECES, PLASMA AND URINE BY HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY, Journal of chromatography B. Biomedical applications, 660(1), 1994, pp. 135-142
Citations number
8
Categorie Soggetti
Chemistry Analytical
Journal title
Journal of chromatography B. Biomedical applications
A simple, rapid and sensitive normal-phase high-performance liquid chr
omatographic (HPLC) method was developed and validated for the determi
nation of a novel hypolipidemic agent in human feces, plasma and urine
. This experimental drug candidate is structurally related to rifamyci
n. The compound and internal standard were isolated from biological ma
trices by a one step liquid-liquid extraction. Separations were achiev
ed on a mu Porasil silica gel column. Recovery and reproducibility ass
essments indicated good accuracy and precision. The overall mean relat
ive recoveries were 93.3% from feces (0.2-20 mu g/mg), 95.1% from plas
ma (20-500 ng/ml) and 97.5% from urine (20-500 ng/ml), with coefficien
ts of variation ranging from 0.7 to 10.0% for feces, 3.0 to 12.7% for
plasma and 2.3 to 10.6% for urine. The limits of quantification were 0
.2 mu g/mg for feces and 20 ng/ml for plasma and urine. The method has
sufficient sensitivity to support clinical trials, and was utilized t
o measure concentrations of the compound in fecal, plasma and urine sa
mples from healthy male volunteers who had received a single 800-mg or
al dose.