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Biovalidation of an SPE‐HPLC‐UV‐fluorescence method for the determination of Valsartan and its metabolite valeryl‐4‐hydroxy‐valsartan in human plasma
Author(s) -
Iriarte Gorka,
Ferreirós Nerea,
Ibarrondo Izaskun,
Alonso Rosa Maria,
Itxaso Maguregui Miren,
Jiménez Rosa Maria
Publication year - 2007
Publication title -
journal of separation science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.72
H-Index - 102
eISSN - 1615-9314
pISSN - 1615-9306
DOI - 10.1002/jssc.200700033
Subject(s) - chromatography , valsartan , bioanalysis , metabolite , chemistry , high performance liquid chromatography , fluorescence spectroscopy , analytical chemistry (journal) , fluorescence , medicine , biochemistry , physics , quantum mechanics , blood pressure , radiology
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 mm×3.9 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.