摘要
目的:建立血浆中美洛昔康浓度RP-HPLC分析方法,并对其在人体内的药代动力学过程进行研究.方法:采用Supelco ODS色谱柱(4.6×250 mm,5mm),流动相为甲醇-pH 7.4磷酸盐缓冲液(1:1,V/V),流速1.0 m1·min-1,检测波长362 nm.结果:美洛昔康在0.05~3 mg·L-1血浆浓度范围内线性关系良好(r=0.9978,n=5),最低检测浓度为0.05mg·L-1.0.1、1.0和2.0mg·L-1三种浓度的日内、日间RSD(n=5)分别为10.71%、9.09%、8.12%和13.96%、11.44%、9.86%;绝对回收率平均(RSD)为80.57%.结论:本实验建立的美洛昔康HPLC测定方法操作方便,结果准确,可用于该药进一步的临床药动学研究.
OBJECTIVE:To establish a RP-HPLC method for the determination andpharmacokinetic study of meloxicam capsules in Chinese healthy men. METHODS:Chromatography was performed on a Supelco ODS (4.6×250 mm, 5mm) withmethylalcohol:pH7.4 phosphate-buffer(l:l,V/V)as mobile phase at 362 nm. Theflow rate was l.0ml.min-l. RESULTS:A good linearity was obtained from 0.05 to 3mg.L-1 of meloxicam in human plasma with reproducibility (r=0.9978,n = 5). The lowerlimit of detection was 0.05mg.L-1 Intra-day and inter-day RSD for assaying theplasma sample containing three concentration of meloxicam were l0.7l%, 9.09%,8.l2% and l3.96%, ll.44%, 9.86% (n=5 ), respectively. The mean absolute recoverywas 80.57%.CONCLUSION:A HPLC method was established to determine meloxicamconcentration in plasma. The method has good selectivity, sensitivity and can beused for further clinical pharmacokinetic study of meloxicam.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2002年第2期137-139,共3页
The Chinese Journal of Clinical Pharmacology