Artículos de revistas
Atenolol Quantification In Human Plasma By High-performance Liquid Chromatography: Application To Bioequivalence Study
Registro en:
Aaps Journal. , v. 5, n. 2, p. XXXIII - XXXIV, 2003.
15507416
2-s2.0-55449084301
Autor
De Abreu L.R.P.
De Castro S.A.C.
Pedrazzoli Jr. J.
Institución
Resumen
An accurate, precise, and sensitive high-performance liquid chromatography (HPLC) assay was developed for the determination of atenolol in human plasma samples to compare the bioavailability of 2 atenolol tablet (50 mg) formulations in 24 volunteers of both sexes. The study had an open, randomized, 2-period crossover design with a 1-week washout period. Plasma samples were obtained over a 24-hour interval. Atenolol concentrations were analyzed by combined reversed phase liquid chromatography and fluorescence detection (λEX = 258 nm, λEM = 300 nm). From the atenolol plasma concentration versus time curves, the following pharmacokinetic parameters were obtained: AUC0-24h, AUC0-∝, and Cmax. The geometric mean of test/reference 50-mg tablets individual percent ratio was 102.2% for AUC0-24h, and 101.6% for Cmax. The 90% confidence intervals (CI) were 100.2% to 105.4% and 100.9% to 103.5%, respectively. Since the 90% CI for both Cmax and AUC0-24h were within the 80% to 125% interval proposed by the Food and Drug Administration, it was concluded that atenolol (50-mg tablets) test formulation was bioequivalent to the reference formulation, with regard to both the rate and extent of absorption. 5 2 XXXIII XXXIV Clementi, W.A., Garvey, T.Q., Clifton, G.D., McCoy, R.A., Brandt, S., Schwartz, S., Single dose pharmacokinetics of (S)-atenolol administered orally as a single enantiomer formulation and as a racemic mixture (Tenormin) (1994) Chirality, 6 (3), pp. 169-174 Egginger, G., Lindner, W., Karh, S., Stoschitzky, K., Stereoselective HPLC bioanalysis of atenolol enantiomers in plasma: Application to a comparative human pharmacokinetic study (1993) Chirality, 5, pp. 506-512 (1999) Physician's Desk Reference-PDR, 51st Ed, p. 1548. , Montvale, NJ: Medical Economics Company, Inc Cruickshank, J.M., McAinsh, J., Atenolol and ischemic heart disease: An overview (1991) Curr Med Res Opin, 12, pp. 485-496 Wadworth, A.N., Murdoch, D., Brogden, R.N., Atenolol: A reappraisal of its pharmacological properties and therapeutic use in cardiovascular disorders (1991) Drugs, 42, pp. 468-510 Psaty, B.M., Koepsell, T.D., Logerfo, J.P., Beta-blockers and primary prevention of coronary heart disease in patients with high blood pressure (1989) JAMA, 261, pp. 2087-2094 Heel, R.C., Brogden, R.N., Speight, T.M., Avery, G.S., Atenolol: A review of its pharmacological properties and therapeutic efficacy in angina pectoris and hypertension (1979) Drugs, 17, pp. 425-460 Majid, P.A., Van Der Vijgh, W.J.F., Wadeh, R., Van Der Wall, E.E., Roos, J.P., Once daily atenolol (Tenormine) in the treatment of angina pectoris (1979) Eur J Cardiol, 9 (6), pp. 419-435 Sitzler, G., Heibel, B., Lucker, P.W., Palm, D., Bioequivalence of two atenolol formulations in healthy volunteers. Evaluation and prediction of effect kinetics at β-adrenoceptors in vivo by means of a radioreceptor assay (1991) Methods Find Exp Clin Pharmacol, 13 (2), pp. 129-137 Yee, Y.G., Ruben, P., Blaschke, T.F., Atenolol determination by high-performance liquid chromatography and fluorescence detection (1993) J Chromatogr, 171, pp. 357-362 Shen, J., Wanwimolruk, S., Hung, C.T., Zoest, A.R., Quantitative analysis of beta-blockers in human plasma by reversed-phase ion-pair high-performance liquid chromatography using a micropore column (1991) J Liq Chromatogr, 14, pp. 777-793 Terry, S., Teitelbaum, Z., A liquid chromatographie method for determination of atenolol in human plasma (1991) J Liq Chromatogr, 1, pp. 3735-3744 Martins, M.L., Pierossi, M.A., Moraes, L.A., Comparative bioavailability of two atenolol tablet formulations after a single dose administration (1997) Int J Clin Pharm Ther, 35 (8), pp. 324-328 Marzo, A., Monti, N.C., Dal Bo, L., Comparative bioavailability of two formulations containing atenolol and chlortalidone associated in a 4:1 fixed combination (2000) Arzneimittelforschung, 50 (9), pp. 802-808 Li, J., Anari, R., Kwok, D., Rapid and simultaneous analysis of seven beta-blockers in human plasma using electrospray LC/MS/MS (1999) AAPS PharmSci, 1 (4), p. 2854 Bioavailability and bioequivalence requirements (1985) Fed Regist, 320, pp. 154-173 Bioavailability and bioequivalence requirements abbreviated applications proposed revisions (1998) Proposed Rule. Fed Regist, 63, pp. 64222-64228 Guidance for industry, bioanalytical methods validation for human studies Food and Drug Administration Web Site, , http://www.fda.gov./cder/guidance/,1998b.August/1998 In vivo bioequivalence guidances (1993) Pharmacopeial Forum, 19, pp. 6501-6508