摘要
目的建立测定人血浆中笨达莫司汀及γ-羟基化苯达莫司汀浓度的高效液相色谱荧光检测法。方法色谱柱为Agilent C_(18)柱(150mm×4.6mm,5μm);流动相为0.01mol·L^(-1)磷酸二氢钾水溶液-乙腈(68:32,v/v);荧光检测器激发波长328nm,发射波长420nm。结果高、中、低3种浓度的苯达莫司汀(16000、5000、500μg·L^(-1))和γ-羟基化苯达莫司汀(800、250、25μg·L^(-1))平均相对回收率分别为96.5%、100.3%、103 3%和98.7%、100.1%、101.3%;绝对回收率分别为54.1%、54.1%、55.6%和62.3%、64.3%、68.5%;日内、日间差RSD均低于5%(n=5);最低定量限分别为200μg·L^(-1)和10μg·L^(-1);线性范围分别为200~20000μg·L^(-1)和10~1000μg·L^(-1)。结论该方法灵敏、准确、简单、快速。
Objective To establish a method for determining the concentration of bendamustine and 7-hydroxylation bendamustine in human plasma by HPLC-FLU. Method The drugs from plasma were analyzed in a HPLC-FLU system. Chromatographic column was Cls column (150 mmx 4.6 mm, 5μm, Agilent, USA); Mobile phase consisted of 0.01 mol.L-1 potassium dihydrogen phosphate-Acetonitrile (68:32, v/v); excitation wavelength was at 352 nm, emission wavelength was at 467 nm. Results In low, middle and high concentrations of bendamustine (500,5000, 16000 μg.L-1) and ?-hydroxylation ndamustine (25,250, 800μg.L-1), the average relative recoveries were 103.3%, 100.3%, 96.5% and 101.3%, 100.1%, 98.7%; The average absolute recoveries were 55.6%, 54.1%, 54.1% and 68.5%, 64.3%, 62.3%; The intra day and inter day variation (RSD) were less than 5% (n=5). The calibration curve of bendamustine and 7-hydroxylation showed good linearity, over the range of 200-20000 μg.L-1 and 10-1000 gg.L-1, The LLOQ were 200 μg.L-l and 10/μg.L-1, respectively. Conclusion The method is sensitive, accurate, easy and quick, which can be used for clinical drug monitoring and pharmacokinetics studies.
出处
《肿瘤药学》
CAS
2011年第1期69-71,共3页
Anti-Tumor Pharmacy