[논문]Simplified HPLC Method for the Determination of Prazosin in Human Plasma and Its Application to Single-dose Pharmacokinetics

Gwak, Hye-Sun; Chun, In-Koo

Simplified HPLC Method for the Determination of Prazosin in Human Plasma and Its Application to Single-dose Pharmacokinetics 원문보기

The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology, v.13 no.2, 2005년, pp.90 - 94

Gwak, Hye-Sun (College of Pharmacy, Ewha Womans University) , Chun, In-Koo (College of Pharmacy, Dongduk Women's University)

Abstract ▼ AI-Helper

Prazosin hydrochloride is an antihypertensive drug with selective ${\alpha}_1$-adrenoreceptor blocking effects. A simple high performance liquid chromatographic method has been developed and validated for the quantitative determination of prazosin in human plasma. A reversed-phase C18 column was used for the separation of prazosin and terazosin (internal standard) with a mobile phase composed of water, acetonitrile and triethylamine(75:25:0.1, V/V;pH5.0) at a flow rate of 1.5 ml/min. the fluorescence detector was set at excitation and emissionwavelengths of 250 and 370 nm, respectively. Intra-and inter-day precision and accuracy were acceptable for all quality control samples including the lower limit of quantification of 0.5 ng/ml. Good recovery (>80%) was seen in plasma. Prazosin was stable in human plasma under various storage conditions. This method was used successfully for a pharmacokinetic study in plasma after oral administration of a single 2-mg dose as prazosin base to 16 healthy volunteers. The maximum plasma concentration of prazosin was 23.1 ${\pm}$ 16.5 ng/ml at 2.1 h, and the mean area under the curve and elimination half-life were calculated to be 108.4 ${\pm}$ 74.2 ng ${\cdot}$hr/ml and 2.5 ${\pm}$ 0.6 h, respectively.

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제안 방법

Intra-day accuracy and precision of the method were estimated by assaying five replicate plasma samples at five different concentrations, in five analytical runs. The overall mean precision was defined by the percentage of relative standard deviation (RSD) of five standards at five different concentrations analyzed on the same day.
Seven calibration samples (0.5, 1, 5, 10, 20, 30 and 50 ng/ ml) were prepared by spiking blank plasma with appropriate volumes of the working solutions. Quality control samples (0.

대상 데이터

The assay was applied to a pharmacokinetic study of prazosin following 2-mg single dose. According to the Guidance for Bioequivalence Testof Korea Food and Drug Administration, eight male and eight female healthy volunteers aged between 19 and 25 years were selected for the study. All subjects gave their written informed consents, and the clinical protocol was approved by the Ethics and Review Committee.
The mobile phase was degassed before use. The fluorescence detector was set at excitation and emission wavelengths of 250 and 370 nm, respectively. All analyses were performed at room temperature.

데이터처리

5 - 50 ng/ml, including the LOQ. Linearity was assessed by a weighted least squares regression coefficient. Calibration curve was found to have a correlation coefficient (r2) of 1, slope of 0.

참고문헌 (13)

Akduman, B. and Crawford, E. D. (2001). Terazosin, doxazosin and prazosin: current clinical experience. Urology 58, 49-54

상세보기
Cheah, P. Y., Yuen, K. H. and Liong, M. L. (2000). Improved high-performance liquid chromatographic analysis of terazosin in human plasma. J Chromatogr. B. Biomed. Sci. Appl. 745, 439-443

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Cho, E. S., Kang, S. H. and Chun, I. K. (2002). Determination of terazosin in human plasma by liquid chromatography and bioequivalence study of teratonin tablets. J Kor. Pharm. Sci. 32, 119-125

원문보기 상세보기
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Sekhar, B. C., Rao, T. R., Sekhar, K. R., Naidu, M. U., Shobha, J. C., Rani, P. U., Kumar, T. V. and Kumar, V. P. (1998). Determination of terazosin in human plasma, using high-performance liquid chromatography with fluorescence detection. J Chromatogr. B. Biomed. Sci. Appl. 710, 137-142

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