title: Determination of minocycline in human plasma by high-performance liquid chromatography coupled to tandem mass spectrometry: application to bioequivalence study.
abstract: Minocycline was determined in human plasma by HPLC-MS-MS using clarithromycin as an internal standard. The method is fast (single liquid extraction and run time of <3 min) and sensitive (5 ng/ml) and it was employed in a bioequivalence study of two 100 mg tablet formulations in 24 healthy volunteers. The 90% confidence interval of the individual ratio geometric mean for both AUC(0-96 h) and Cmax were 99.2-111.1% and 95.6-117.5%, respectively. Thus, Minoderm was considered bioequivalent to Minomax according to both the rate and extent of absorption. No food interaction was observed with either formulation.
authors.affiliation: Department of Pharmacology, ICB-University of São Paulo, Brazil.
authors.forename: M V
authors.initials: MV
authors.lastname: Araujo
authors.forename: D R
authors.initials: DR
authors.lastname: Ifa
authors.forename: W
authors.initials: W
authors.lastname: Ribeiro
authors.forename: M E
authors.initials: ME
authors.lastname: Moraes
authors.forename: M O
authors.initials: MO
authors.lastname: Moraes
authors.forename: G
authors.initials: G
authors.lastname: de Nucci
mesh_terms: D000284:Administration, Oral; D000900:Anti-Bacterial Agents / Q000097:blood* / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D017291:Clarithromycin / Q000592:standards; D018565:Food-Drug Interactions; D006801:Humans; D013058:Mass Spectrometry; D008911:Minocycline / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics*; D012015:Reference Standards; D013607:Tablets; D013810:Therapeutic Equivalency
chemical_list: D000900:Anti-Bacterial Agents; D013607:Tablets; D008911:Minocycline; D017291:Clarithromycin