title: Atenolol quantification in human plasma by high-performance liquid chromatography: application to bioequivalence study.
abstract: 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 (lambda(EX) = 258 nm, lambda(EM) = 300 nm). From the atenolol plasma concentration versus time curves, the following pharmacokinetic parameters were obtained: AUC(0-24h), AUC(0- infinity ), and C(max). The geometric mean of test/reference 50-mg tablets individual percent ratio was 102.2% for AUC(0-24h), and 101.6% for C(max). The 90% confidence intervals (CI) were 100.2% to 105.4% and 100.9% to 103.5%, respectively. Since the 90% CI for both C(max) and AUC(0-24h) 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.
authors.affiliation: Department of Pharmacology, Faculty of Medical Sciences-UNICAMP, Campinas, São Paulo, Brazil. lrpabreu@uol.com.br
authors.forename: Luis Renato Pires
authors.initials: LR
authors.lastname: de Abreu
authors.forename: Silvana Aparecida Calafatti
authors.initials: SA
authors.lastname: de Castro
authors.forename: José
authors.initials: J
authors.lastname: Pedrazzoli
mesh_terms: D000959:Antihypertensive Agents / Q000097:blood*; D001262:Atenolol / Q000097:blood*; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D005260:Female; D006801:Humans; D008297:Male; D011786:Quality Control; D012015:Reference Standards; D012680:Sensitivity and Specificity; D013607:Tablets; D013810:Therapeutic Equivalency
chemical_list: D000959:Antihypertensive Agents; D013607:Tablets; D001262:Atenolol