LC_ESI_MS法测定血浆中枸橼酸喷托维林浓度及其应用.docVIP

LC-ESI/MS法测定血浆中枸橼酸喷托维林浓度及其应用 余克花1, 温金华2, 聂福根3, 熊玉卿2* (1. 南昌大学医学院实验教学部, 江西南昌 330006; 2. 南昌大学医学院临床药理研究所, 江西南昌 330006; 3. 南昌市第三医院, 江西南昌 330009 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 4 mmol·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1~160 ng·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。 关键词: 枸橼酸喷托维林; LC-ESI/MS; 生物等效性; 药代动力学 中图分类号: R917 文献标识码:A 文章编号: 0513-4870 (2009 12-1402-04 Quantification of pentoxyverine citrate in human plasma by LC-ESI/MS method and its application YU Ke-hua1, WEN Jin-hua2, NIE Fu-gen3, XIONG Yu-qing2* (1. Department of Experimental Teaching, College of Medicine, Nanchang University, Nanchang 330006, China; 2. Institute of Clinical Pharmacology, College of Medicine, Nanchang University, Nanchang 330006, China; 3. Nanchang Third Hospital, Nanchang 330009, China Abstract: 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, inter- and 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. Key words: pentoxyverine citrate; LC-ESI/MS; bioequivalence; pharmacokinetics 愈酚维