Determination of torasemide in human plasma and its bioequivalence study by high-performance liquid chromatography with electrospray ionization tandem mass spectrometry
Determination of torasemide in human plasma and its bioequivalence study by high-performance liquid chromatography with electrospray ionization tandem mass spectrometry作者机构:Key Laboratory of Drug Quality Control and Pharmacovigilance(Ministry of Education)China Pharmaceutical University State Key Laboratory of Natural Medicine China Pharmaceutical University
出 版 物:《Journal of Pharmaceutical Analysis》 (药物分析学报(英文版))
年 卷 期:2016年第6卷第2期
页 面:95-102页
核心收录:
学科分类:0710[理学-生物学] 1007[医学-药学(可授医学、理学学位)] 1002[医学-临床医学] 081704[工学-应用化学] 07[理学] 0817[工学-化学工程与技术] 08[工学] 070302[理学-分析化学] 0703[理学-化学] 0702[理学-物理学] 10[医学]
基 金:funded by Jiangsu D&R Pharmaceutical Corporation (Taizhou PR China)
主 题:Torasemide HPLC-ESI-MS Human plasma Bioequivalence Pharmacokinetics
摘 要:A sensitive and selective method using high-performance liquid chromatography coupled with elec- trospray ionization tandem mass spectrometry (HPLC-ESI-MS) to determine the concentration of tor- asemide in human plasma samples was developed and validated. Tolbutamide was chosen as the internal standard (IS). The chromatography was performed on a GI Sciences Inertsil ODS-3 column (100 mm× 2.1 mm i.d., 5.0 μm) within 5 min, using methanol with 10 mM ammonium formate (60:40, v/ v) as mobile phase at a flow rate of 0.2 mL/min. The targeted compound was detected in negative io- nization at m/z 347.00 for torasemide and 269.00 for IS. The linearity range of this method was found to be within the concentration range of 1-2500 ng/mL (r=0.9984) for torasemide in human plasma. The accuracy of this measurement was between 94.05% and 103.86%. The extracted recovery efficiency was from 84.20% to 86.47% at three concentration levels. This method was also successfully applied in pharmacokinetics and bioequivalence studies in Chinese volunteers.