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KMID : 0369820050350060461
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Jorunal of Korean Pharmaceutical Sciences
2005 Volume.35 No. 6 p.461 ~ p.465
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Validation of a Simple HPLC Method for Determination of Nicardipine in Human Plasma and Its Application to Single-dose Pharmacokinetics
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임호택/Im HT
조성희/이헌우/박완수/류재환/최영욱/용철순/이경태/Cho SH/Lee HW/Park WS/Rew JH/Choi YW/Yong CS/Lee KT
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Abstract
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A simple HPLC method with ultraviolet detection of nicardipine in human plasma was developed and validated. After drug extraction with solid phase extraction (SPE) method, chromatographic separation of nicardipine in plasma was achieved at 30?C with a C18 column and acetonitrile-0.02% phosphate buffer mixture (with 0.02% triethylamine, final pH 7.0), as mobile phase. Quantitative determination was performed by ultraviolet detection at 254 nm. The method was specific and validated with a limit of quantification of 5 ng/mL. The intra- and inter-day precision and accuracy were acceptable for all quality control samples including the lower limit of quantification. The applicability of the method was demonstrated by analysis of plasma after oral administration of a single 40 mg dose to 8 healthy subjects. From the plasma nicardipine concentration versus time curves, the mean AUCt, was 134.04±59.72nghr/mL and Cmax of 108.65±69.17ng/mL reached 1.5 hr after administration. The mean biological half-life of nicardipine was 3.93±0.82hr. Based on the results, this simple and validated assay method could readily be used in any pharmacokinetic or bioequivalence studies using human.
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KEYWORD
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Nicardipine hydrochloride, Validation, Bioavailability, HPLC
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