LC-MS/MS法测定健康人血浆中的特比萘芬  

Determination of Terbinafine in Human Plasma by LC-MS/MS

作　　者：李博[1] 步芬[1] 陈沄[2] 赵霞[3] 

机构地区：[1]中国药科大学食品质量与安全教研室,南京210009 [2]中国医学科学院皮肤病研究所,南京210042 [3]无锡市第二人民医院药物临床试验机构办公室,无锡214002

出　　处：《药学与临床研究》2011年第6期504-507,共4页Pharmaceutical and Clinical Research

摘　　要：目的:建立一种快速测定人血浆中特比萘芬血药浓度的LC-MS/MS法。方法:采用C18柱(4.6 mm×150 mm,5μm),柱温30℃,流动相为甲醇-水(含20 mmol.L-1乙酸铵)(95∶5),流速1.0 mL.min-1;气动辅助电喷雾离子化(ESI),正离子模式多反应离子检测(MRM);特比萘芬和内标(酮康唑)分别为:m/z 292.00→141.10,m/z 530.95→82.10。结果:特比萘芬在10.3～2054 ng.mL-1范围内线性关系良好(r=0.9978),定量下限10.27 ng.mL-1。特比萘芬低、中、高三个浓度批内及批间相对标准偏差、准确度、绝对回收率均符合方法学要求,无显著基质效应。结论:该方法专属性强、分析周期短,适合于临床上特比萘芬血浆含量的测定。Objective： To develope a rapid liquid chromatography tandem mass spectrometry method for the quantification of terbinafine in human plasma.Methods： Separation was performed using a C18 column（4.6 mm×150 mm,5 μm）maintained at 30℃ and the mobile phase consisting of a mixture of methyl alcohol and water（containing 20 mmol·L-1 ammonium acetate）（95∶5） was delivered at a flow rate of 1.0 mL·min-1.The analytes were analyzed by electro-spray ionization（ESI） in a multiple reaction monitoring（MRM） mode.The precursor to product ion transition of m/z 292.00→141.10 and m/z 530.95→82.10 were used to measure terbinafine and the internal standard（ketoconazole）,respectively.Results： The linearity ranged from 10.3 to 2054 ng·mL-1（r=0.9978）;the limit of quantification of terbinafine in human plasma was 10.3 ng·mL-1.The intra-and inter-assay precisions,accuracy and absolute recovery met the requirement of a bioanalytical method,the method was absent of matrix effects.Conclusion： The method is selective and suitable for the clinical quantification of terbinafine in human plasma.

关 键 词：特比萘芬 LC-MS/MS 血浆 

分 类 号：R969.1[医药卫生—药理学]