应用高效液相色谱法测定人血清及尿样中索他洛尔浓度

HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC DETERMINATION OF SOTALOL IN HUMAN'SIN SERUM AND URINE

本文建立了测定人血清及尿样中索他洛尔（ｓｏｔａｌｏｌ）的反相ＨＰＬＣ方法。索他洛尔及内标氨酰心安（ａｔｅｎｏｌｏｌ）的色谱分析采用氰基分析柱及保护柱，流动相为乙腈：甲醇：１０％磷酸：１０％正丁胺（７５：２５：０．２：０．１，ｖ／ｖ）。流速为１．８ｍｌ／ｍｉｎ。血样及碱化尿样用溶剂萃取（氯仿：异丙醇４：１，ｖ／ｖ），采用荧光检测器检测，其激发和发射波长分别为２２０ｎｍ及３１３ｎｍ。实验结果表明：索他洛尔与内标的分离良好，其保留时间为３．５ｍｉｎ和５．０ｍｉｎ。在血样及尿样中的萃取的绝对回收率：索他洛尔＞９０％；内标＞８０％。线性范围：血样为０－５ｍｇ／ｌ（０．９９９９）；尿样为０－５０ｍｇ／ｌ（０．９９９８）。日内及日间差异均小于１０％。最低检测下限为０．０１３ｍｇ／ｌ。本方法适用于索他洛尔的药代动力学研究。

A simple and sensitive HPLC method for the measurement of sotalol in human serum and urine has been developed.Seperation was obtained using a NovPak CN column.The mobile phase is consisted of a mixture of acetonitrile-methanol-10% phosphoric acid-10% buthylamine(75:25:0.2:0.1,v/v).Sotalol and internal standard.atenolol.were extracted from serum or alkalinized urine into chloroform-2-propanol(4:1,v/v).The retention times of sotalol and I.S.were 3.5 min and 5.0 min respectively.Within-day and day to day coefficients of variation were less than 10% in serum and in urine.Calibration was linear from 0-5.0 mg/1 in serum(r=0.9999)and from 0-50mg/1 in urine(r=0.9998).The limit of detection was 0.013 mg/1 with spectrofluorimetric detector at 220 nm excitation and 313 nm emmision wavelength.This method has been demonstrated to be suitable for pharmacokinetic study comparing with other report.