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采用高效液相色谱法测定人血浆中新型抗心律失常药物ACC-9358

Determination of a novel antiarrhythmic agent ACC-9358 in human plasma by high-performance liquid chromatography.

作者信息

Achari R, Thomas D A

机构信息

Pharmaceutical Research Department, Du Pont Critical Care, Waukegan, Illinois 60085.

出版信息

Pharm Res. 1988 Mar;5(3):190-2. doi: 10.1023/a:1015973108928.

DOI:10.1023/a:1015973108928
PMID:3244633
Abstract

A liquid chromatographic method for the determination of ACC-9358, an antiarrhythmic agent, in human plasma is described. ACC-9358 was extracted from plasma into chloroform and back extracted into 0.01 N hydrochloric acid. ACC-9358 in the acidic extract was eluted from a Novapak C18 column using a 87:13:0.1 (by volume) mixture of phosphate buffer (pH 3.0), acetonitrile, and triethylamine as the mobile phase and measured at 280 nm. The average extraction recoveries were 78.4 and 85.4% at the 0.5- and 5-micrograms/ml level, respectively. Standard curves were linear and reproducible over the concentration range of 0.01-10 micrograms/ml, with coefficients of determination better than 0.999. Coefficients of variation for both within-day and day-to-day analysis were less than 11%. The assay method is sensitive, reproducible, and suitable for disposition studies of ACC-9358 in humans.

摘要

本文描述了一种测定人血浆中抗心律失常药物ACC - 9358的液相色谱方法。ACC - 9358从血浆中萃取至氯仿,再反萃取至0.01 N盐酸中。酸性萃取液中的ACC - 9358以磷酸盐缓冲液(pH 3.0)、乙腈和三乙胺按体积比87:13:0.1的混合物作为流动相,从NovaPak C18柱上洗脱,并在280 nm处进行测定。在0.5微克/毫升和5微克/毫升水平下,平均萃取回收率分别为78.4%和85.4%。标准曲线在0.01 - 10微克/毫升浓度范围内呈线性且可重复,决定系数优于0.999。日内和日间分析的变异系数均小于11%。该测定方法灵敏、可重复,适用于ACC - 9358在人体中的处置研究。

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