Development and Validation of HPLC-UV Method for the Determination of Diclofenac in Human Plasma with Application to a Pharmacokinetic Study

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dc.contributor.authorArisoy, Gulsum Gul
dc.contributor.authorDural, Emrah
dc.contributor.authorMergen, Gorkem
dc.contributor.authorArisoy, Mustafa
dc.contributor.authorGuvendik, Gulin
dc.contributor.authorSoylemezoglu, Tulin
dc.date.accessioned2019-07-27T12:10:23Z
dc.date.accessioned2019-07-28T09:44:29Z
dc.date.available2019-07-27T12:10:23Z
dc.date.available2019-07-28T09:44:29Z
dc.date.issued2016
dc.department[Arisoy, Gulsum Gul -- Dural, Emrah -- Mergen, Gorkem -- Soylemezoglu, Tulin] Ankara Univ, Inst Forens Sci, Dept Forens Toxicol, Ankara, Turkey -- [Dural, Emrah] Cumhuriyet Univ, Dept Pharmaceut Toxicol, Fac Pharm, Ankara, Turkey -- [Mergen, Gorkem] TechKnowledge FZ LLC, Dubai, U Arab Emirates -- [Arisoy, Mustafa] Ankara Univ, Dept Pharmaceut Chem, Fac Pharm, Ankara, Turkey -- [Guvendik, Gulin] Ankara Univ, Dept Pharmaceut Toxicol, Fac Pharm, Ankara, Turkeyen_US
dc.description.abstractA simple, rapid and reliable high performance liquid chromatography method (HPLC) with ultraviolet detection (UV) was developed and validated according to ICH guidelines, for quantitative analysis and therapeutic drug monitoring of diclofenac sodium (DS) in human plasma. Plasma samples (0.7 mL) were acid hydrolysis by 100 mu L, 1 M hydrochloric acid. Analytes were concentrated from plasma by liquid-liquid extraction with 2 mL ethyl acetate by repeated twice, which allows to obtain good extraction yields (98.75%-99.32%). The separation was achieved by employing C18 analytical column (3.5 mu m particle size, 150 mmx3.9 mm I.D.) under isocratic conditions using acetonitrile and NaH2PO4 mixture (42.5: 57.5, v/v) as mobile phase (pH: 3.16) flow rate of 1.5 mL/min. Naproxen (3 mu g/mL) was used as an internal standard (IS). The DS and IS were detected at 281 nm and eluted at 2.6 and 6.2 min, respectively. Total run time was 7 min. Method showed linearity with very good determination coefficients (r(2)=0.999), over the concentration range of 50 - 1600 ng/mL. Limits of detection (LOD) and quantification (LOQ) were 8.95 ng/mL and 27.12 ng/mL, respectively. Intra-day precision and accuracy were between 0.93-5.27; 1.74-9.81, respectively. Inter-day precision and accuracy were between 2.71-6.64; 2.03-9.16, respectively. This method was successfully applied for determination of DS plasma concentrations during a pharmacokinetic study in healthy volunteers (n=12) after an oral administration of Voltaren (R) 75 mg/tablet and remarkable variations in DS levels were observed. In our study, on the contrary to equivalent doses of DS, the observed significant differences in plasma levels of DS, on 2nd, 4th and 6th hours, can be explained by pharmacokinetic differences, that arise from mainly polymorphisms of CYP2C9 and CYP3A4, which are major enzymes responsible for DS metabolism.en_US
dc.identifier.doi10.4274/tjps.2016.02en_US
dc.identifier.endpage299en_US
dc.identifier.issn1304-530X
dc.identifier.issue3en_US
dc.identifier.scopus2-s2.0-85012124696en_US
dc.identifier.scopusqualityQ3
dc.identifier.startpage292en_US
dc.identifier.urihttps://dx.doi.org/10.4274/tjps.2016.02
dc.identifier.urihttps://hdl.handle.net/20.500.12418/7079
dc.identifier.volume13en_US
dc.identifier.wosWOS:000396697500002en_US
dc.identifier.wosqualityN/A
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.language.isoenen_US
dc.publisherTURKISH PHARMACISTS ASSOCen_US
dc.relation.ispartofTURKISH JOURNAL OF PHARMACEUTICAL SCIENCESen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectDiclofenac sodiumen_US
dc.subjectValidationen_US
dc.subjectPlasmaen_US
dc.subjectHigh performance liquid chromatographyen_US
dc.subjectUltraviolet detectionen_US
dc.titleDevelopment and Validation of HPLC-UV Method for the Determination of Diclofenac in Human Plasma with Application to a Pharmacokinetic Studyen_US
dc.typeArticleen_US

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