title: LC determination of entacapone in tablets: in vitro dissolution studies.
abstract: The aim of the study was to develop and validate a dissolution procedure for entacapone-coated tablets. Several conditions such as medium composition, pH, surfactant concentration, and rotation speed were evaluated. The best dissolution conditions were achieved using apparatus 2, 900 mL of medium containing acetate buffer pH 5.3 at a rotation speed of 50 rpm, and a reversed-phase liquid chromatographic method for the quantification of the drug from the dissolution test, as well as to evaluate the dissolution profiles for tablets. The procedure was validated by specificity, linearity, accuracy, repeatability, intermediate precision, and robustness. The chromatographic method employed an Agilent Eclipse XDB RP-18 (150 × 4.6 mm i.d., particle size 5 μm) with a mobile phase consisting of water pH 3.0 and acetonitrile (65:35, v/v) at a flow rate of 2.0 mL/min. The dissolution procedure developed and validated was adequate for its purpose and could be applied for quality control for entacapone-coated tablets because there is no official monograph.
authors.affiliation: Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul, Porto Alegre-RS, Brazil. csoldatelli30@hotmail.com
authors.forename: Clésio S
authors.initials: CS
authors.lastname: Paim
authors.forename: Magda T
authors.initials: MT
authors.lastname: Martins
authors.forename: Marcelo D
authors.initials: MD
authors.lastname: Malesuik
authors.forename: Martin
authors.initials: M
authors.lastname: Steppe
mesh_terms: D000978:Antiparkinson Agents / Q000032:analysis* / Q000737:chemistry*; D002396:Catechols / Q000032:analysis* / Q000737:chemistry*; D056148:Chromatography, Reverse-Phase / Q000379:methods*; D006863:Hydrogen-Ion Concentration; D016014:Linear Models; D009570:Nitriles / Q000032:analysis* / Q000737:chemistry*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012995:Solubility; D013608:Tablets, Enteric-Coated / Q000032:analysis / Q000737:chemistry
chemical_list: D000978:Antiparkinson Agents; D002396:Catechols; D009570:Nitriles; D013608:Tablets, Enteric-Coated; C071192:entacapone