同位素稀释质谱法测定人血浆中奥氮平的方法学及生物等效性研究(英文)  被引量:3

Development and validation of a liquid chromatography-isotope dilution tandem mass spectrometry for determination of olanzapine in human plasma and its application to bioavailability study

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作  者:张梦琪[1] 贾晶莹[1] 陆川[1] 刘罡一[1] 余成寅[2] 桂雨舟 刘昀[1] 刘艳梅[1] 王伟[4] 李水军[1] 余琛[1] 

机构地区:[1]上海市徐汇区中心医院中心实验室,上海200031 [2]上海中医药大学中药学院,上海201203 [3]上海医药临床研究中心,上海200233 [4]上海市徐汇区中心医院急诊监护室,上海200031

出  处:《药学学报》2010年第6期767-771,共5页Acta Pharmaceutica Sinica

摘  要:建立简便、可靠、灵敏的同位素稀释质谱法测定血浆中奥氮平的浓度。50μL血浆样品中加入稳定同位素(奥氮平-D3)为内标,经特丁基甲醚提取后进样分析。色谱柱为XBridge Shield RP 18(100mm×2.1mm,3.5μm,Waters)。乙腈-缓冲液(氨水-醋酸铵,pH8)为流动相,等度洗脱,流速0.4mL·min-1。扫描方式为正离子多离子反应监测(MRM)。定量下限均为0.1ng·mL-1,线性范围为0.1~30ng·mL-1。对特异性、线性、准确度、精密度、回收率、介质效应均进行了方法学考察,且各项结果均符合要求,可以用于奥氮平的生物等效性研究。A simple,reliable and sensitive liquid chromatography-isotope dilution mass spectrometry(LC-ID/MS) was developed and validated for quantification of olanzapine in human plasma.Plasma samples(50 μL) were extracted with tert-butyl methyl ether and isotope-labeled internal standard(olanzapine-D3) was used.The chromatographic separation was performed on XBridge Shield RP 18(100 mm × 2.1 mm,3.5 μm,Waters).An isocratic program was used at a flow rate of 0.4 mL·min-1 with mobile phase consisting of acetonitrile and ammonium buffer(pH 8).The protonated ions of analytes were detected in positive ionization by multiple reactions monitoring(MRM) mode.The plasma method,with a lower limit of quantification(LLOQ) of 0.1 ng·mL-1,demonstrated good linearity over a range of 0.1 - 30 ng·mL-1 of olanzapine.Specificity,linearity,accuracy,precision,recovery,matrix effect and stability were evaluated during method validation.The validated method was successfully applied to analyzing human plasma samples in bioavailability study.

关 键 词:奥氮平 同位素稀释质谱 血浆 

分 类 号:R917[医药卫生—药物分析学]

 

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