摘要
建立快速、简捷、灵敏的LC-ESI/MS法测定人血浆中枸橼酸喷托维林的浓度,并用于含此种成分的复方愈酚维林胶囊的药代动力学与生物等效性的研究。血浆样品经液-液萃取后以甲醇与含0.4%冰乙酸和4mmol·L-1乙酸铵的水(43∶57,v/v)为流动相,采用ESI源以SIM方式对血浆样品中枸橼酸喷托维林进行定量分析。研究结果表明,枸橼酸喷托维林血浆浓度测定方法的线性范围为1～160ng·mL-1,日内、日间精密度(RSD)均小于12.5%,方法回收率为92%～110%,提取回收率大于80%。本法操作简便、快速、灵敏度高、专属性强,满足生物样本的分析要求,可用于枸橼酸喷托维林的生物等效性与药代动力学研究。
A rapid and sensitive liquid chromatography-electrospray ionization-mass spectrometry （LC-ESI/ MS） method for quantification of pentoxyverine citrate in human plasma has been developed and applied for the bioequivalence and pharmacokinetics study. After extracted from plasma samples with ethyl acetate, analysis was performed in selected ion monitoring （SIM） mode with a positive electrospray ionization （ESI） interface with a mobile phase consisted of methanol and water （0.4% glacial acetic acid and 4 mmol.L^-1 ammonium acetate, 43 ： 57, v/v）. The linear concentration range of the calibration curves was 1.0-160.0 ng.mL^-1 for pentoxyverine citrate, interand intra-precision （RSD） was less than 12.5%, accuracy （RE） was in ±13.5% and absolute recovery was more than 80%. The method was proved simple, rapid, sensitive, specific and suitable for pharmacokinetic and bioequivalence study of Yufenweilin capsule containing pentoxyverine citrate.
出处
《药学学报》
CAS
CSCD
北大核心
2009年第12期1402-1405,共4页
Acta Pharmaceutica Sinica
