B. Ramsauer et al., HIGHLY SENSITIVE HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC ASSAY FOR 1-BETA-D-ARABINOFURANOSYLCYTOSINE-5'-STEARYL PHOSPHATE (CYTARABINE-OCFOSFATE), Journal of chromatography B. Biomedical applications, 665(1), 1995, pp. 183-192
Citations number
19
Categorie Soggetti
Chemistry Analytical
Journal title
Journal of chromatography B. Biomedical applications
An ion-pair HPLC method for the determination of 1-beta-D-arabinofuran
osylcytosine-5'-stearyl phosphate (cytarabine-ocfosfate I) was develop
ed, using a phenyl-bonded column under reversed-phase conditions with
a mobile phase of acetonitrile-buffered water (pH 6.8) (50:50) for iso
cratic elution. A reproducible sample clean-up was achieved by solid-p
hase extraction. In order to reach the low limit of detection of 2 ng/
ml, an enrichment switching system was used. The present validation le
ads to a limit of quantification of 5 ng/ml with a coefficient of vari
ation (C.V.) of 10%. The total time of measurement was shortened by a
back-flush procedure to restore the conditions after each run. UV dete
ction at 275 nm was applied. The recoveries for plasma samples ranged
from 56.4 to 64.1%, regardless of drug concentrations. The intra-assay
C.V. was about 4% (40 measurements at four different concentrations).
The inter-assay recovery (ten measurements over ten days) at a plasma
concentration of 50 ng/ml was 57% with a C.V. of 8.25%. Based on this
HPLC method, the pharmacokinetics of I were measured during a clinica
l phase I/II study.