Development of a LC-MS/MS for Quantification of Venlafaxine in Human Plasma and Application to Bioequivalence Study in healthy Korean Subjects

Abstract

A simple, rapid and selective liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) is developed and validated for quantification of venlafaxine in human plasma with simple liquid-liquid extraction step consisted of extraction with ether and dichloromethane for 10 min and mixing with 1 M sodium acetate in human plasma using fluoxetine as an internal standard (IS). The analyte are separated using an isocratic mobile phase consisted of acetonitrile and 5 mM ammonium formate (4/3, v/v) on a isocratic YMC hydrosphere C18 (2. .9986, 1/x 2 weighting). The lower limit of quantification (LLOQ) was 1.0 ng/mL. The retention times of venlafaxine and IS were 0.6 min and 0.7 min that means the potential for the highthroughput potential of the proposed method. In addition, no significant metabolic compounds were found to interfere with the analysis. Acceptable precision and accuracy were obtained for the concentrations over the standard curve range. The validated method was successfully applied to bioequivalence study after 75-mg of venlafaxine sustained-release (SR) capsule in 24 healthy Korean subjects.

Recent advances in liquid chromatographic methods for the determination of selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors

“…Kang et al () developed a high‐throughput HPLC–MS/MS method for venlafaxine quantitation with fluoxetine as the IS. Human plasma samples were liquid–liquid extracted by ether–dichloromethane 7:3, which was unique because ethyl acetate was the dominant choice of extractant in almost all other recent LLE processes.…”

A comparative study of different electrodeposited NiCo2O4 microspheres anchored on a reduced graphene oxide platform: electrochemical sensor for anti-depressant drug venlafaxine

“…Aer a careful literature survey, it was revealed that most of the analytical methods for determination of VEN are HPLC methods. [4][5][6][7][8][9][10][11][12] However, these methods face some drawbacks including the cost of equipment, consumption of large volumes of solvents and requirement of several pretreatment procedures for biological samples. Also, thin layer chromatography (TLC) was described for VEN analysis in bulk and capsules.…”

Development and Validation of Venlafaxine Hydrochloride in Bulk and in Capsule Formulation by HPTLC

“…Chromatographic estimation of Venlafaxine HCl was reported by using few HPLC methods either in combination or individual in pharmaceutical dosage form [9][10][11][12]. In the same context a method for estimation by HPTLC was also available as reported to study the degradation kinetics [13] and also HPTLC analysis of Venlafaxine hydrochloride in the bulk drug and tablets [14].…”