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Validation of a Simple HPLC Method for Determination of Nicardipine in Human Plasma and Its Application to Single-dose Pharmacokinetics

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

  • Published : 2005.12.20

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 $30^{\circ}C$ with a $C_{18}$ 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 $AUC_{t}$, was $134.04{\pm}59.72\;ng\;hr/mL$ and $C_{max}$ of $108.65{\pm}69.17\;ng/mL$ reached 1.5 hr after administration. The mean biological half-life of nicardipine was $3.93{\pm}0.82\;hr$. Based on the results, this simple and validated assay method could readily be used in any pharmacokinetic or bioequivalence studies using human.

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References

  1. Y. Kishi, F. Okumura and H. Furuya, Haemodynamic effects of nicardipine hydrochloride. Studies during its use to control aeute hypertension in anaesthetized patients, Br. J. Anaesth., 56, 1003-1007 (1984) https://doi.org/10.1093/bja/56.9.1003
  2. E.S. Hysing, J.E. Chelly, M.F. Doursout, C. Hartley and R.G Merin, Cardiovascular effects of and interaction between calcium blocking drugs and anesthetics in chronically instrumented dogs. III. Nicardipine and isoflurane, Anesthesiology, 65, 385-391 (1986) https://doi.org/10.1097/00000542-198610000-00007
  3. E.M. Sorkin and S.P. Clissold, Nicardipine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy, in the treatment of angina pectoris, hypertension and related cardiovascular disorders, Drugs, 33, 296-345 (1987) https://doi.org/10.2165/00003495-198733040-00002
  4. R.J. Eastwood, C. Galustian, R.K. Bharnra and D.W. Holt, High-performance liquid chromatographic method for the measurement of nicardipine in plasma or serum, J. Chromatogr. B. Biomed. Sci. Appl., 530, 463-468 (1990) https://doi.org/10.1016/S0378-4347(00)82351-8
  5. S. Higuchi and S. Kawamura, Specific determination of plasma nicardipine hydrochloride levels by gas chromatography-mass spectrometry, J. Chromatogr B. Biomed. Sci. Appl., 223, 341-349 (1981) https://doi.org/10.1016/S0378-4347(00)80106-1
  6. 식품의약품안전청 고시 제 2002-60 호, 생물학적동등성 시험기준 (2002. 11. 22)
  7. K. Li, X. Zhang, Y.S. Yuan and F.L. Zhao, A high-performance liquid chromatographic method for the determination of nicardipine in plasma and its application to pharmacokinetics in humans, Biomed. Chromatogr., 12, 326-329 (1998) https://doi.org/10.1002/(SICI)1099-0801(199811/12)12:6<326::AID-BMC755>3.0.CO;2-M