title: Biovalidation of an SPE-HPLC-UV-fluorescence method for the determination of valsartan and its metabolite valeryl-4-hydroxy-valsartan in human plasma.
abstract: A simple and fast method for the simultaneous determination of the antihypertensive drug Valsartan and its metabolite in human plasma has been validated. The proposed method deals with SPE, followed by an HPLC separation coupled with fluorimetric and photometric detection. The optimization of the SPE-HPLC method was achieved by an experimental design. The separation was performed on an RP C18 Atlantis 100 mmx3.9 mm column. The mobile phase consisted of a mixture of ACN 0.025% TFA and phosphate buffer (5 mM, pH = 2.5) 0.025% TFA and was delivered in gradient mode at a flow rate of 1.30 mL/min. The eluent was monitored with a fluorescence detector at 234 and 378 nm excitation and emission wavelengths, respectively, and at 254 nm using a photometric detector. The full analytical validation was performed according to the Food and Drug Administration (FDA) 'guidance for industry: bioanalytical method validation' and the recoveries obtained for Valsartan and its metabolite ranged from 94.6 to 108.8%. The validated method was successfully applied to 12 plasma samples obtained from patients under antihypertensive treatment with Valsartan.
authors: Kimika Analitikoaren Saila, Zientzia eta Teknologia Fakultatea, Euskal Herriko Unibertsitatea/UPV, Bilbo, Basque Country, Spain.
authors: Gorka
authors: G
authors: Iriarte
authors: Nerea
authors: N
authors: Ferreirós
authors: Izaskun
authors: I
authors: Ibarrondo
authors: Rosa Maria
authors: RM
authors: Alonso
authors: Miren
authors: M
authors: Itxaso Maguregui
authors: Rosa Maria
authors: RM
authors: Jiménez
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000097:blood / Q000592:standards; D001774:Blood Chemical Analysis / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012015:Reference Standards; D052616:Solid Phase Extraction / Q000379:methods*; D013056:Spectrophotometry, Ultraviolet; D013777:Tetrazoles / Q000097:blood* / Q000592:standards; D014633:Valine / Q000031:analogs & derivatives* / Q000097:blood / Q000592:standards; D000068756:Valsartan
chemical_list: D000959:Antihypertensive Agents; C494196:N-(1-oxo-4-hydroxypentyl)-N-((2'-(1H-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-L-valine; D013777:Tetrazoles; D000068756:Valsartan; D014633:Valine