Determination of torasemide in human plasma and its bioequivalence study by high-performance liquid chromatography with electrospray ionization tandem mass spectrometry

作     者：Lin Zhang Rulin Wang Yuan Tian Zunjian Zhang 

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.