SourceJ Pharm Biomed Anal 2010 Mar 11; 51(4)
A sensitive, specific and selective liquid chromatography/tandem mass spectrometric method has been developed and validated for the simultaneous determination of irbesartan and hydrochlorothiazide in human plasma. Plasma samples were prepared using protein precipitation with acetonitrile, the two analytes and the internal standard losartan were separated on a reverse phase C(18) column (50mmx4mm, 3microm) using water with 2.5% formic acid, methanol and acetonitrile (40:45:15, v/v/v (%)) as a mobile phase (flow rate of 0.70mL/min). Irbesartan and hydrochlorothiazide were ionized using ESI source in negative ion mode, prior to detection by multiple reaction monitoring (MRM) mode while monitoring at the following transitions: m/z 296-->269 and m/z 296-->205 for hydrochlorothiazide, 427-->175 for irbesartan. Linearity was demonstrated over the concentration range 0.06-6.00microg/mL for irbesartan and 1.00-112.00ng/mL for hydrochlorothiazide. The developed and validated method was successfully applied to a bioequivalence study of irbesartan (300mg) with hydrochlorothiazide (12.5mg) tablet in healthy volunteers (N=36).
MeshAdministration, OralAdolescentAdultAngiotensin II Type 1 Receptor BlockersBiphenyl CompoundsCalibrationChemical PrecipitationChromatography, High Pressure LiquidCross-Over StudiesDiureticsDrug CombinationsDrug StabilityHumansHydrochlorothiazideMaleMiddle AgedReproducibility of ResultsSpectrometry, Mass, Electrospray IonizationTabletsTandem Mass SpectrometryTetrazolesTherapeutic EquivalencyYoung Adult
Journal Article Randomized Controlled Trial Validation Studies