Determination of indinavir, an HIV-protease inhibitor, in human plasma by reversed-phase high-performance liquid chromatography.
A sensitive high-perforrmance liquid chromatographic assay has been developed to determine the concentrations of the HIV-protease inhibitor indinavir in human plasma. The sample pretreatment involved a protein precipitation procedure using 100 microl of human plasma and 400 microl of acetonitrile. Chromatography was carried out on an Octadecyl column using a mobile phase of acetonitrile-water (40:60, v/v). The water phase contained 50 mM phosphate buffer pH 6 and 4 g/l tetramethylammoniumchloride. Ultraviolet detection at 210 nm was used. The method has been validated with regard to specificity, detection limit, lower and upper limit of quantitation, recovery, accuracy, and inter- and intra-assay precision. Stability tests under various conditions were performed. The bioanalytical assay is now in use for the determination of indinavir in several clinical pharmacokinetic studies in HIV-infected patients.
Burger
D M
DM
Department of Clinical Pharmacy, University Hospital Nijmegen, The Netherlands.
de Graaff
M
M
Wuis
E W
EW
Koopmans
P P
PP
Hekster
Y A
YA
D000097:Acetonitriles / Q000737:chemistry; D000284:Administration, Oral; D000328:Adult; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D002940:Circadian Rhythm; D004355:Drug Stability; D015658:HIV Infections / Q000097:blood* / Q000188:drug therapy / Q000378:metabolism; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D006801:Humans; D019469:Indinavir / Q000008:administration & dosage / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D008297:Male; D008875:Middle Aged; D009994:Osmolar Concentration; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013056:Spectrophotometry, Ultraviolet; D013997:Time Factors
D000097:Acetonitriles; D017320:HIV Protease Inhibitors; D019469:Indinavir; C032159:acetonitrile