Rapid high-performance liquid chromatography-tandem mass spectrometry method for simultaneous measurement of venlafaxine and O-desmethylvenlafaxine in human plasma and its application in comparative bioavailability study.
A rapid high-performance liquid chromatography-tandem mass spectrometry method has been developed and validated for simultaneous measurement of venlafaxine and O-desmethylvenlafaxine in human plasma using fluoxetine as an internal standard. In the liquid-liquid extraction method, compounds and internal standard were extracted from plasma using methyl tertiary butyl ether as an extraction solvent. The HPLC separation of the analytes was performed on a Zorbax SB-C(18), 50 x 4.6 mm, 5 microm column, using a isocratic elution program using a mobile phase consisting of HPLC-grade methanol: 5 mm ammonium acetate (80:20 v/v) at a flow-rate of 1.0 mL/min with a total runtime of 3.0 min. The proposed method has been validated with a linear range of 4-400 ng/mL for venlafaxine and 5-500 ng/mL for O-desmethyl venlafaxine. The method was applied for a bio-equivalence study of 75 mg tablets formulation in 32 Indian male healthy subjects under fasting conditions.
Rajasekhar
D
D
Department of Chemistry, SriVenkateswa University, Tirupati, India.
Kumar
I Jaswanth
IJ
Venkateswarlu
P
P
D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003511:Cyclohexanols / Q000097:blood* / Q000493:pharmacokinetics; D000069468:Desvenlafaxine Succinate; D006801:Humans; D057230:Limit of Detection; D015203:Reproducibility of Results; D017367:Selective Serotonin Reuptake Inhibitors / Q000097:blood* / Q000493:pharmacokinetics; D053719:Tandem Mass Spectrometry / Q000379:methods*; D000069470:Venlafaxine Hydrochloride
D003511:Cyclohexanols; D000069468:Desvenlafaxine Succinate; D017367:Selective Serotonin Reuptake Inhibitors; D000069470:Venlafaxine Hydrochloride