HPLC-ESI-MS法测定人血浆盐酸氨溴索浓度  

Determination of ambroxol hydrochloride in human plasma by HPLC-ESI-MS

作　　者：谷清[1] 冯文利[1] 吴华[1] 于晓佳[1] 司徒伟[1] 朱莹[1] 张佳丽[1] 王华光[1] 于伟越[1] 王鹤尧[1] 

机构地区：[1]首都医科大学附属北京朝阳医院药事部,北京100020

出　　处：《中国新药杂志》2008年第9期772-774,共3页Chinese Journal of New Drugs

摘　　要：目的:建立高效液相色谱-质谱联用法测定人血浆中氨溴索浓度的方法。方法:血浆样品经NaOH碱化,乙醚提取浓缩后,以乙腈-水(85:15)为流动相,流速:0.2 mL·min^(-1),采用电喷雾离子源(ESI),以多离子反应监测方式(MRM)进行正离子检测,氨溴索和内标地西泮的定量分析离子对分别为m/z 378.9→263.9和m/z 285.1→193.1。结果:血浆样品中氨溴索线性范围0.26～200μg·L^(-1)(r=0.9998),最低定量限为0.26ng·mL^(-1)。低、中、高(0.78,12.5,100μg·L^(-1))3种浓度的日内RSD分别为9.1%,8.3%和2.7%;日间RSD分别为10.0%,7.2%和12.4%;准确度为109%,114%和106%。结论:本方法灵敏度高、专属性强、重现性好、准确,可用于人血浆中氨溴索的含量测定。Objective ： To establish a HPLC-MS-MS method for determining the concentration of ambroxol in human plasma. Methods：Ambroxol and diazepam （internal standard） in plasma were extracted by diethyl ether after being alkalized by NaOH, and determined by LC/MS/MS method with the mobile phase consisting of acetonitrile-H2O（85： 15 ） , at a flow rate of 0.2 mL· min^-1. ESI source was applied and operated in the positive ion mode. The multiple reaction monitoring （MRM） mode use the transitions of m/z 130.2→71.0 and m/z 206. 1→59.9 were used to quantily the ambroxol and the diazepam, respectively. Results：The linear range of ambroxol was 0.26 - 200μg·L ^- 1 （ r = 0. 999 8 ）. The lower limit of quantitation of metformin was 0.26μg· L^-1. At low, middle and high concentration （0.78,12.5,100μg·L^-1） , the intra-day RSDs were 9.1% ,8. 3% and 2.7% ;the interday RSDs were 10.0% ,7.2% and 12.4% ;and the accuracy rates were 109% , 114% 和 106%. Conclusion：The method is sensitive, specific, reproducible and accurate, and suitable for the study of pharmacokinetics and bioequivalence of ambroxol in human body.

关 键 词：氨溴索 高效液相色谱-质谱联用法 血浆浓度 

分 类 号：R927.2[医药卫生—药学] R974.1