High-performance liquid chromatographic assay for the quantitation of irbesartan (SR 47436/BMS-186295) in human plasma and urine.
A selective, accurate, precise and reproducible high-performance liquid chromatographic assay was developed for the quantitation of irbesartan, an angiotensin II antagonist, in human plasma and urine samples. The method involved solid-phase extraction of irbesartan and internal standard (I.S.) using a 100-mg Isolute CN cartridge. A portion of the eluate was injected onto an ODS analytical column connected to a fluorescence detector that was set at an excitation wavelength of 250 nm and an emission wavelength of 371 nm. The mobile phase consisted of 50% acetonitrile and a 50% weak phosphate-triethylamine solution, pH 3.5, at a flow-rate of 0.8 ml/min. The assay was linear from 1 to 1000 ng/ml with both plasma and urine. In either matrix, the lower limit of quantitation was 1 ng/ml. The analyses of quality control samples indicated that the nominal values could be predicted with an accuracy >95%. The inter- and intra-day coefficients of variation for the analyses in both matrices were <8%. Irbesartan was stable in both human plasma and urine for at least seven months at -20 degrees C. The application of the assay to a pharmacokinetic study is described.
Chang
S Y
SY
Department of Metabolism and Pharmacokinetics, Bristol-Myers Squibb Pharmaceutical Research Institute, New Brunswick, NJ 08903-0191, USA.
Whigan
D B
DB
Vachharajani
N N
NN
Patel
R
R
D000284:Administration, Oral; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000032:analysis* / Q000737:chemistry / Q000493:pharmacokinetics; D001713:Biphenyl Compounds / Q000008:administration & dosage / Q000032:analysis* / Q000737:chemistry / Q000493:pharmacokinetics; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D002940:Circadian Rhythm; D004355:Drug Stability; D006801:Humans; D000077405:Irbesartan; D016014:Linear Models; D008297:Male; D009994:Osmolar Concentration; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013777:Tetrazoles / Q000008:administration & dosage / Q000032:analysis* / Q000737:chemistry / Q000493:pharmacokinetics; D013997:Time Factors
D000959:Antihypertensive Agents; D001713:Biphenyl Compounds; D013777:Tetrazoles; D000077405:Irbesartan