Quantification Of Oxcarbazepine Research Articles

Development and validation of an enantioselective SFC-MS/MS method for simultaneous separation and quantification of oxcarbazepine and its chiral metabolites in beagle dog plasma.

A rapid and sensitive assay based on supercritical fluid chromatography-tandem mass spectrometry (SFC-MS/MS) has been developed and validated for the determination of oxcarbazepine (OXC) and its chiral metabolite licarbazine (Lic) in beagle dog plasma using carbamazepine as internal standard. Chiral analysis in a run time of only 3 min was performed on an ACQUITY UPC(2) ™ Trefoil™ CEL2 column (3.0 × 150 mm, 2.5 μm) at 50 °C by isocratic elution with a mobile phase of supercritical carbon dioxide (purity ≥ 99.99%) and methanol (60:40, v/v) at a flow rate of 2.3 mL/min. The assay was linear over the concentration ranges 5-1000 ng/mL for OXC and 0.5-100 ng/mL for the enantiomers of Lic with corresponding lower limits of quantitation of 5 ng/mL and 0.5 ng/mL. Intra- and inter-day precisions were in the range 0.78-14.14% with accuracies in the range -10.80% to 0.42%. The method was successfully applied to a pharmacokinetic study involving a single oral administration of 16 mg/kg OXC as Trileptal(@) tablets to beagle dogs.

Controlling Bioanalytical Variability: A Perennial Quest

BioanalysisVol. 5, No. 15 CommentaryControlling bioanalytical variability: a perennial questManish S Yadav & Pranav S ShrivastavManish S Yadav* Author for correspondenceClinical Research & Bioanalysis, R&D Centre, Alkem Laboratories limited, Taloja, Raigad-410208, Maharashtra, India. Search for more papers by this authorEmail the corresponding author at ysmanish@yahoo.com & Pranav S ShrivastavDepartment of Chemistry, School of Sciences, Gujarat University, Ahmedabad-380009, Gujarat, IndiaSearch for more papers by this authorPublished Online:1 Aug 2013https://doi.org/10.4155/bio.13.134AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleKeywords: bioanalytical variabilitybiological matrixphospholipids associated matrix interferencereal sampleregulated bioanalysisspiked sampleunidentified co-eluting matrix componentsReferences1 Trufelli H, Palma P, Famiglini G, Cappiello A. An overview of matrix effects in liquid chromatography–mass spectrometry. Mass Spectrom. Rev.30,491–509 (2011).Crossref, Medline, CAS, Google Scholar2 Cappiello A, Famiglini G, Palma P, Pierini E, Termopoli V, Trufelli H. 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Anal.53,745–750 (2010).Crossref, Medline, CAS, Google ScholarFiguresReferencesRelatedDetailsCited ByImpact of electrospray ion source platforms on matrix effect due to plasma phospholipids in the determination of rivastigmine by LC–MS/MSVikas Trivedi, Vivek Upadhyay, Manish Yadav, Pranav S Shrivastav & Mallika Sanyal10 November 2014 | Bioanalysis, Vol. 6, No. 17 Vol. 5, No. 15 Follow us on social media for the latest updates Metrics Downloaded 170 times History Published online 1 August 2013 Published in print August 2013 Information© Future Science LtdKeywordsbioanalytical variabilitybiological matrixphospholipids associated matrix interferencereal sampleregulated bioanalysisspiked sampleunidentified co-eluting matrix componentsFinancial & competing interests disclosureThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download

Quantification of Oxcarbazepine and Its Active Metabolite 10-Hydroxycarbazepine in Human Plasma by High-performance Liquid Chromatography

A simple, sensitive and selective high-performance liquid chromatography (HPLC) method with ultraviolet detection (230 nm) was developed and validated for the quantification of oxcarbazepine (CAS 28721-07-5), a new antiepileptic drug, and its active metabolite 10-hydroxycarbazepine (CAS 29331-92-8) in human plasma. Following solid-phase extraction, the analytes and internal standard (zaleplon, CAS 151319-34-5) were separated using an isocratic mobile phase on a reverse phase C18 column. The lower limit of quantification was 50 ng/mL for oxcarbazepine and 100 ng/mL for 10-hydroxycarbazepine with a relative standard deviation of less than 10%. A linear dynamic range of 50 to 5000 ng/mL for oxcarbazepine and of 100 to 10000 ng/mL for 10-hydroxycarbazepine was established. This HPLC method was validated with between-batch precision of 0.8 to 8.6% and 3.2 to 7.5% for oxcarbazepine and 10-hydroxycarbazepine respectively. The between-batch accuracy was 94.0 to 102.4% and 95.4 to 105.6%, respectively. Stability of oxcarbazepine and 10-hydroxycarbazepine in plasma was excellent, with no evidence of degradation during sample processing (autosampler) and 30 days storage in a freezer. This validated method is sensitive, simple and repeatable enough to be used in pharmacokinetic studies.

Impact of Oxcarbazepine Sulfate Metabolite on Incurred Sample Reanalysis and Quantification of Oxcarbazepine

Recently, incurred sample reanalysis (ISR) has become a requirement in bioanalysis. The general guidance recommends investigating ISR failure to evaluate the suitability of an analytical method. In the case of acceptable ISR evaluation, there were no precise recommendations for further testing when sporadic values were obtained. The ISR evaluation performed during a bioequivalence study for the anticonvulsant drug oxcarbazepine showed acceptable ISR results, but one particular chromatographic anomaly led to a thorough investigation. The finding of these tests showed that an oxcarbazepine phase II metabolite occasionally co-eluted with the drug and impacted oxcarbazepine's quantitation through in-source conversion. This paper demonstrates the necessity of rigorous interpretation of ISR results and close monitoring of all subject sample results.

Narrow-bore liquid chromatographic assay for oxcarbazepine and its major metabolite in rat brain, liver and blood microdialysates

An isocratic narrow-bore high-performance liquid chromatographic assay with UV detection is described for the detection of oxcarbazepine and its major metabolite, 10,11-dihydro-10-hydroxycarbamazepine, using carbamazepine as the internal standard. This method is sufficiently sensitive to allow quantification of oxcarbazepine and its metabolite in rat brain, liver and blood microdialysates.