LC-MS法测定人血浆中人参三醇二琥珀酸酯钠含量的方法学研究  

Methodology study on determination of Sodium Panaxatriol Disuccinate in human plasma by LC-MS

作　　者：李华龙[1] 吴燕[1] 米亚娴[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《药物评价研究》2009年第2期104-106,共3页Drug Evaluation Research

摘　　要：目的:建立测定人血浆中人参三醇二琥珀酸酯钠的液相色谱-质谱联用法。方法:色谱柱为Shimadzu VP-C18柱(150mm×2.0mm,5μm);乙腈-10mmol/L乙酸铵水溶液(55∶45)为流动相,体积流量0.3mL/min;柱温40℃;内标物吲达帕胺。质谱条件为电喷雾离子源(ESI),选择负离子提取方式检测,人参三醇二琥珀酸酯钠和吲达帕胺的选择检测离子分别为m/z675.5([M-Na+H]+)、m/z364.1([M+H]+)。结果:人参三醇二琥珀酸酯钠线性范围为0.0304～101.3μg/mL,定量下限为0.0304μg/mL。准确度、精密度以及稳定性均符合有关要求。结论:本方法专属性强,灵敏度高,适用于人血浆中人参三醇二琥珀酸酯钠的药代动力学研究。Objective: To develop a sensitive and specific LC-MS method for the determination of sodium panaxatriol disuccinate in human plasma. Methods: Separation was carried out on a Shimadzu VP-ODS analytical column (150 mm × 2.0 mm, 5 μm) with a mobile phase of CH3CN-10 mmol/L ammonium acetate (55:45) at a flow rate of 0.3 mL/min. The internal standard was Indapamide. ESI was applied and operated in negative mode. The ion of monitor: m/z 675.5 (sodium panaxatriol disuccinate), m/z 364.1 (Indapamide). Results: The linear calibration curve was observed in the concentration range of 0.030 4-101.3 μg/mL. The lower limit quantification was 0.030 4 μg/mL. The accuracy, precision (intra-day and inter-day), sensitivity and stability (ambient temperature, freeze/thaw, freeze storage) of the method fulfilled the guideline of the analytical validation criteria. Conclusion: The method with specificity is sensitive, rapid and suitable for pharmacokinetics study on sodium panaxatriol disuccinate in human plasma.

关 键 词：血药浓度 LC-MS 人参三醇二琥珀酸酯钠 

分 类 号：R969.1[医药卫生—药理学]