A High-Performance Liquid Chromatographic Method for the Simultaneous Determination of Venlafaxine and O-Desmethylvenlafaxine in Biological Fluids

Hicks, David; Wolaniuk, Donna; Russell, Anita; Cavanaugh, Nancy; Kraml, M.

doi:10.1097/00007691-199402000-00016

Cited by 70 publications

(41 citation statements)

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“…The literature data indicated that the absolute recovery of VEN and ODV was generally higher for LLE (85% VEN 32% ODV [6], 92% VEN, and 99% ODV [9]) than for SPE (above 73% [5] or 75-99% [8] for both drugs) and their modifications, such as LPME (41% VEN, 42% ODV) [10], CPE (93% VEN) [7], and SBSE (50-92% for both analytes) [11]. In this study the extraction yield for VEN was about 100% for both concentration and for ODV the absolute recovery exceeded 92%.…”

Section: Extraction Yieldmentioning

confidence: 99%

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Simultaneous quantitation of venlafaxine and its main metabolite, O -desmethylvenlafaxine, in human saliva by HPLC

Dziurkowska

Wesołowski

2013

J. Sep. Science

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Venlafaxine is used for the treatment of major depression and generalized anxiety disorders. Because its active metabolite, O-desmethylvenlafaxine, has also a similar activity, the purpose of this work was to develop a simple method for simultaneous quantitation of both drugs using HPLC with UV detection. The saliva was chosen as diagnostic material because of its easy accessibility and possibility of sampling by patients, for example, at home. The sample pretreatment by liquid-liquid extraction allows to separate both compounds from this diagnostic material with a high recovery, varying between 92.65 and 104.78%. The major advantage of the validated method lies in its sensitivity, reproducibility, and specificity for routine quantitation of the venlafaxine and O-desmethylvenlafaxine in the human saliva. The low detection and quantification values (2.8-3.1 and 9.4-10.2 ng/mL, respectively) enable to quantify both species excreted with saliva at the nanogram level. The applicability of the method was verified by analysis of the saliva obtained from depressed women treated with venlafaxine. The results suggest that the method could be used for therapeutic drug monitoring in patients undergoing treatment with venlafaxine, especially when metabolic anomalies or low compliance are suspected, or in the case of polypharmacy.

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Section: Extraction Yieldmentioning

confidence: 99%

“…There were also attempts to use urine for that purpose [9]. Moreover, VEN and ODV were determined in postmortem tissues [13][14][15] and animals organs, such as rat liver [10] and brain [11].…”

Section: Introductionmentioning

confidence: 99%

Simultaneous quantitation of venlafaxine and its main metabolite, O -desmethylvenlafaxine, in human saliva by HPLC

Dziurkowska

Wesołowski

2013

J. Sep. Science

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“…[5,6] In humans, VEN is metabolized into two minor metabolites, N-desmethylvenlafaxine (NDV) and N,O-didesmethylvenlafaxine (DDV), and the major active metabolite, O-desmethylvenlafaxine (ODV) which presents an activity profile similar to that of VEN. [7] Desvenlafaxine succinate (DVS), the succinate salt of the isolated major active metabolite, is currently under clinical development and may be a new se-…”

Section: Introductionmentioning

confidence: 99%

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

Kang

Kim

et al. 2014

Transl Clin Pharmacol

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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.

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“…Several methods have been described to determine venlafaxine in biological fluids [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22]. The techniques used include CE with UV and MS detection [7][8][9][10][11][12], GC [13][14][15] and HPLC with UV [16][17][18], MS/MS [19], coulometric [20], electrochemical [21] and flourimetric [22] detections. Makhija and Vavia have studied the stability of venlafaxine by HPLC [18], without characterizing the products of degradation.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous separation and determination of process-related substances and degradation products of venlafaxine by reversed-phase HPLC

Rao¹,

Raju

2006

J. Sep. Sci.

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A simple and rapid gradient RP HPLC method for simultaneous separation and determination of venlafaxine and its related substances in bulk drugs and pharmaceutical formulations has been developed. As many as four process impurities and one degradation product of venlafaxine have been separated on a Kromasil KR100-5C18 (4.6 mm x 250 mm; particle size 5 microm) column with gradient elution using 0.3% diethylamine buffer (pH 3.0) and ACN/methanol (90:10 v/v) as a mobile phase. The column was maintained at 40 degrees C and the eluents were monitored with photo diode array detection at 225 nm. The chromatographic behaviour of all the compounds was examined under variable compositions of different solvents, temperatures, buffer concentrations and pH. The method was validated in terms of accuracy, precision and linearity as per ICH guidelines. The inter- and intraday assay precision was < 4.02% (%RSD) and the recoveries were in the range of 96.19-101.14% with %RSD < 1.15%. The correlation coefficients (r2) for calibration curves of venlafaxine as well as impurities were in the range of 0.9942-0.9999. The proposed RP-LC method was successfully applied to the analysis of commercial formulations and the recoveries of venlafaxine were in the range of 99.32-100.67 with %RSD <0.58%. The method could be of use not only for rapid and routine evaluation of the quality of venlafaxine in bulk drug manufacturing units but also for the detection of its impurities in pharmaceutical formulations. Forced degradation of venlafaxine was carried out under thermal, photo, acidic, basic and peroxide conditions and the acid degradation products were characterized by ESI-MS/MS, 1H NMR and FT-IR spectral data.

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A High-Performance Liquid Chromatographic Method for the Simultaneous Determination of Venlafaxine and O-Desmethylvenlafaxine in Biological Fluids

Cited by 70 publications

References 0 publications

Simultaneous quantitation of venlafaxine and its main metabolite, O -desmethylvenlafaxine, in human saliva by HPLC

Simultaneous quantitation of venlafaxine and its main metabolite, O -desmethylvenlafaxine, in human saliva by HPLC

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

Simultaneous separation and determination of process-related substances and degradation products of venlafaxine by reversed-phase HPLC

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