采用固相萃取和高效液相色谱-质谱联用技术测定人血浆中的卡托普利：在生物等效性研究中的应用。
Determination of captopril in human plasma, using solid phase extraction and high-performance liquid chromatography, coupled to mass spectrometry: application to bioequivalence study.
作者信息
Rezende Kênnia R, Mundim Iram M, Teixeira Leonardo S, Souza Weidson C, Ramos Douglas R, Cardoso Cláudio R F, Souza Inácia C, Gratão Mário Z, Bellório Karini B
机构信息
Faculty of Pharmacy, Federal University of Goiás, UFG, Pça Universitária com 1(a), Avenida S/N Setor Universitário, Goiânia-GO, Goiás CEP 74605-220, Brazil.
出版信息
J Chromatogr B Analyt Technol Biomed Life Sci. 2007 May 1;850(1-2):59-67. doi: 10.1016/j.jchromb.2006.11.007. Epub 2006 Dec 4.
A specific high performance liquid chromatography-mass spectrometric (LC-MS/MS) assay was developed for the determination of captopryl in plasma. The retention time was 1.45 and 1.37 min for captopril and enalapril, respectively. The overall mean recovery, using SPE extraction with OASIS HLB cartridges, was found to be 107.2+/-9.5 and 100.04+/-2%, respectively. Calibration curves were linear in the concentration range of 10.00-2000.00 ng/ml, and the lower limit of quantification (LLOQ) was 10.00 ng/ml. The LLOQ was sensitive enough for detecting terminal phase concentrations of the drug. Inter-batch precision of the method ranged from 0.88 to 1.95%. Intra-batch accuracy ranged from 97.15 to 105.77%, while intra-batch precision ranged from 2.49 to 5.66% at concentrations of 30.00, 760.00 and 1500.00 ng/ml. The developed method was applied to study bioequivalence of captopril in a group of 25 human subjects at a single oral dose of a 50mg tablet.
建立了一种用于测定血浆中卡托普利的高效液相色谱 - 质谱联用（LC - MS/MS）特定分析方法。卡托普利和依那普利的保留时间分别为1.45分钟和1.37分钟。使用OASIS HLB柱进行固相萃取（SPE），总体平均回收率分别为107.2±9.5%和100.04±2%。校准曲线在10.00 - 2000.00 ng/ml浓度范围内呈线性，定量下限（LLOQ）为10.00 ng/ml。LLOQ足够灵敏以检测药物的终末相浓度。该方法的批间精密度范围为0.88%至1.95%。在30.00、760.00和1500.00 ng/ml浓度下，批内准确度范围为97.15%至105.77%，批内精密度范围为2.49%至5.66%。所建立的方法应用于研究25名人类受试者单次口服50mg片剂时卡托普利的生物等效性。
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