QUANTITATIVE ANALYTICAL METHODS FOR THE DETERMINATION OF A NEW HYPERTENSION DRUG, CGS-25462, AND ITS METABOLITES (CGS 25659 AND CGS-24592) IN HUMAN PLASMA BY HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY
Wm. Maniara et al., QUANTITATIVE ANALYTICAL METHODS FOR THE DETERMINATION OF A NEW HYPERTENSION DRUG, CGS-25462, AND ITS METABOLITES (CGS 25659 AND CGS-24592) IN HUMAN PLASMA BY HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY, Journal of chromatography B. Biomedical sciences and applications, 706(2), 1998, pp. 287-294
Citations number
2
Categorie Soggetti
Chemistry Analytical","Biochemical Research Methods
Journal title
Journal of chromatography B. Biomedical sciences and applications
Two simple and sensitive reversed-phase high-performance liquid chroma
tography (HPLC) methods were developed and validated for the quantitat
ive determination of a novel hypertension drug CGS 25462 and its major
metabolites CGS 24592 and CGS 25659 in human plasma. CGS 25462 and CG
S 25798 (internal standard) were purified by one-step liquid-liquid ex
traction with methylene chloride. The metabolites were analyzed on HPL
C after plasma protein precipitation with 10% trichloroacetic acid (TC
A). Separations were achieved on a Zorbax RX C-18 column. All compound
s were detected by using a fluorescence detector. The excitation wavel
ength was 254 nm, and emission was monitored at 325+/-12.5 nm. Assessm
ent of recovery and reproducibility indicated good accuracy and precis
ion. Over the validation concentration range of 10 to 1000 ng/ml for C
GS 25462 and 25 to 5000 ng/ml for both metabolites, overall mean relat
ive recoveries were 96% for CGS 25462, 101% for CGS 25659 and 107% for
CGS 24592, and the coefficients of variation were 4.6 to 13% for CGS
25462, 9.5 to 13% for CGS 25659 and 7.7 to 15% for CGS 24592. The limi
ts of quantification (LOQs) were 10 ng/ml for CGS 25462 and 25 ng/ml f
or CGS 24592 and CGS 25659, which were of sufficient sensitivity to me
asure the concentrations of CGS 25462, CGS 25659 and CGS 24592 in plas
ma samples from normal volunteers following a single 800 mg oral dose.
(C) 1998 Published by Elsevier Science B.V.