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

• Main Authors: Lin Zhang (Author), Rulin Wang (Author), Yuan Tian (Author), Zunjian Zhang (Author)
• Format: Book
• Published: Elsevier, 2016-04-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.
• Notes: 2095-1779; 10.1016/j.jpha.2015.11.002
• Keywords: Torasemide; HPLC-ESI-MS; Human plasma; Bioequivalence; Pharmacokinetics; Therapeutics. Pharmacology; RM1-950
• Source: Journal of Pharmaceutical Analysis, Vol 6, Iss 2, Pp 95-102 (2016)

A sensitive and selective method using high-performance liquid chromatography coupled with electrospray ionization tandem mass spectrometry (HPLC-ESI-MS) to determine the concentration of torasemide in human plasma samples was developed and validated. Tolbutamide was chosen as the internal standard (IS). The chromatography was performed on a Gl 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 ionization 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.