Faculty of Pharmacy, University of Jordan, Amman, Jordan. l.tutunji@ju.edu.jo

J Pharm Biomed Anal 2010 Mar 11; 51(4) :985-90.

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).

Administration, Oral
Adolescent
Adult
Angiotensin II Type 1 Receptor Blockers
Biphenyl Compounds
Calibration
Chemical Precipitation
Chromatography, High Pressure Liquid
Cross-Over Studies
Diuretics
Drug Combinations
Drug Stability
Humans
Hydrochlorothiazide
Male
Middle Aged
Reproducibility of Results
Spectrometry, Mass, Electrospray Ionization
Tablets
Tandem Mass Spectrometry
Tetrazoles
Therapeutic Equivalency
Young Adult

eng

Journal Article Randomized Controlled Trial Validation Studies

20004542