高效液相色谱-质谱联用法测定人血浆中非索非那定的浓度(1)
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[摘要] 目的：建立以高效液相色谱-质谱联用法测定人血浆中非索非那定浓度的方法。方法：以苯乙双胍为内标物，采用C18柱，流动相由乙腈及30 mmol/ml NH4Ac(含0.1%甲酸，0.01%三氟乙酸)组成，采用梯度洗脱程序，测定血浆中非索非那定浓度。结果：非索非那定在2.26～676.46 ng/ml线性关系良好(r=0.999 6，n=7)，定量下限浓度为2.26 ng/ml，RSD为0.7%，高、中、低浓度测定的相对回收率分别为(109.9±1.7)%、(103.1±7.2)%和(101.5±13.4)%，日内RSD分别为2.1%、2.5%和9.8%，日间RSD分别为1.3%、5.7%和7.1%。结论：所建方法预处理简单﹑专属性强、灵敏度高，适合测定非索非那定的血药浓度。
[关键词] 非索非那定；血药浓度；LC-MS/MS
[中图分类号] R969.1 [文献标识码]A[文章编号]1673-7210(2011)08(a)-028-03
Determination of Fexofenadine in human plasma by LC-MS/MS
ZHANG Hong1, LI Jianhe2, ZHU Yungui2, WANG Feng2, YI Lidan2
1.Department of Pharmacy, the People′s Hospital of Xiangxi Autonomous Perfecture, Xiangxi 416000, China; 2.Department of Medicine, the Second Xiangya Hospital of Central South University, Changsha 410011, China
[Abstract] Objective: To establish the LC-MS/MS method for the determination of fexofenadine in human plasma. Methods: Phenformin was used as internal standard. C18 column was used with the mobile phase of acetonitrile and 30 mmol/mlNH4Ac (containing 0.1% formic acid and 0.01% trifluoraceticacid). The concentration of fexofenadine in human plasma was determined by the method of LC-MS/MS with gradient elution. Results: A linearity was obtained from 2.26 to 676.46 ng/ml of fexofenadine in human plasma with a good correlation coefficient (r=0.999 6, n=7), with the quantitative lower limit was 2.26 ng/ml. RSD was 0.7%. The mean recoveries were (109.9±1.7)%, (103.1±7.2)% and (101.5±13.4)% respectively in the quality control samples of high, middle and low concentration. The RSD with in day and between day were 2.1%, 2.5%, 9.8% (n=5) and 1.3%, 5.7%, 7.1% (n=5), respectively. Conclusion: The method can be applied to determine the fexofenadine concentration in plasma.
[Key words] Fexofenadine; Plasma concentration; LC-MS/MS
非索非那定(fexofenadine)是特非那定在人体的活性代谢产物，是组胺H1受体拮抗药，无抗胆碱和抗肾上腺素受体作用，属于无镇静作用的第二代抗组胺药[1-2]，无心血管不良反应，并具有一定的抗炎作用，用于治疗变应性疾病，如季节性变应性鼻炎(包括与此相关的眼部症状)、常年性变应性鼻炎和慢性特发性荨麻疹，效果良好[3-4]。非索非那定在人血浆中的含量测定方法主要为高效液相-紫外检测法(HPLC-U V)[5-9]和高效液相-荧光检测法(HPLC-FLD)[10-13] ......
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