【作者】 杨远荣； 张隽； 王文琼； 李华荣； 高逢喜；

【Author】 YANG Yuan-rong,ZHANG Juan,WANG Wen-qiong,LI Hua-rong,GAO Feng-xi(The Affiliated Jingzhou Hospital to Tongji Medical College of Huazhong University of Science Technology,Hubei Jingzhou 434020,China)

【机构】 华中科技大学同济医学院附属荆州医院；

【摘要】 目的:建立测定人血浆中盐酸氨溴索的高效液相色谱法。方法:色谱柱:ZORBAX EclipseXDB-C18(4.6mm×150mm,5um);保护柱:EclipseXDB-C18(4.6mm×12.5mm,5um;);流动相:乙腈:磷酸氢二胺缓冲液(PH7.0)=45:55;紫外检测波长:242nm;流速:1.0mL/min;柱温:30℃;内标:盐酸地尔硫卓。结果:回归方程线性关系良好,回归方程为:A=0.0021C+0.0295,r=0.99985,n=5,线性范围为10～640ng·ml-1,最低检测浓度为5ng/ml。低、中、高(20、160、480ng·mL-1)三种浓度的绝对回收率和相对回收率分别为90.6%、85.6%、91.8%和112.4%、89.8%、93.3%。日内、日间RSD均小于10%。结论:该方法适用于测定人血浆中盐酸氨溴索含量,结果准确、可靠。更多还原

【Abstract】 OBJECTIVE TO develop an HPLC methods for determination Ambroxol Hydrochloride in human plasma . METHODS Chromatographic determination was performed on Eclipse XDB-C18 (4.6mm×150mm,5um) with acetonitrile-Diammonium Hydrogen Phosphate buffer(PH7.0)(45/50,v/v) as mobile phase and the flow rate of 1.0mL/min ; Detection wavelength was 242nm;The temperature of column was 30℃;ISTD was Diltiazem Hydrochloride.RESULTS The linear regression equation was A = 0.0021 C + 0.0295,r=0.99985,n=5,the linearity range was obtained from 10ng·ml-1 to 640ng·ml-1 ; Lower Limit of quantitation was 5ng/ml;The extraction recoveries and relatively recoveries for high、medium、low concentration was 90.6%、85.6%、91.8% and 12.4%、89.8%、93.3%.The relative standard deviations of the intra-day and inter-day was less than 10%.CONCLUSIONS The study provides a simple and reliable method for determination of Ambroxol Hydrochloride by HPLC in Human Plasma.更多还原