인체 혈장 중 니카르디핀의 정량을 위한 HPLC 분석법 검증 및단일 용량 투여에 의한 약물동태 연구

Abstract

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 30oC 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±59.72 ng•hr/mL and Cmax of 108.65±69.17 ng/mL reached 1.5 hr after administration. The mean biological half-life of nicardipine was 3.93±0.82 hr. Based on the results, this simple and validated assay method could readily be used in any pharmacokinetic or bioequivalence studies using human.