Ms. Stelling et al., A QUANTITATIVE ANALYTICAL METHOD FOR THE DETERMINATION OF A NEW ANXIOLYTIC (CGS 19480A) IN HUMAN PLASMA USING HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY, BMC. Biomedical chromatography, 8(6), 1994, pp. 288-290
A sensitive and specific analytical method has been developed for the
determination of a new anxiolytic (CGS 19480A) in human plasma using h
igh performance liquid chromatography (HPLC). The drug and internal st
andard (CGS 18102A), were extracted with hexane at pH 7. Separations w
ere achieved by reversed phase chromatography on a Nucleosil 5 C-18 co
lumn at a flow rate of 1.0 mL/min. The mobile phase consisted of aceto
nitrile: 0.01 M phosphate buffer (pH 7): methanol (51:35:14, v:v:v), w
here the final pH of the mobile phase was adjusted to 4.0 using 85% ph
osphoric acid. Plasma standard curves were linear from 5.0 to 500 ng/m
l, with recovery of the drug being greater than 95% at all concentrati
ons. The method was validated over a concentration range of 5.0 to 500
ng/mL with a limit of quantification of 5.0 ng/mL. The method was suc
cessfully applied to the analysis of clinical samples from a single-do
se safety and tolerability study conducted in six healthy male volunte
ers.