Determination of minocycline in human plasma by high-performance liquid chromatography coupled to tandem mass spectrometry: application to bioequivalence study.
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.
Araujo
M V
MV
Department of Pharmacology, ICB-University of São Paulo, Brazil.
Ifa
D R
DR
Ribeiro
W
W
Moraes
M E
ME
Moraes
M O
MO
de Nucci
G
G
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
D000900:Anti-Bacterial Agents; D013607:Tablets; D008911:Minocycline; D017291:Clarithromycin