title: LC-MS/MS method for the determination of agomelatine in human plasma and its application to a pharmacokinetic study.
abstract: A sensitive and selective LC-MS/MS method for the determination of agomelatine in human plasma was developed and validated. After simple liquid-liquid extraction, the analytes were separated on a Zorbax SB-C18 column (150 × 2.1 mm i.d., 5 µm) with an isocratic mobile phase consisting of 5 mm ammonium acetate solution (containing 0.1% formic acid) and methanol (30:70, v/v) at a flow-rate of 0.3 mL/min. The MS acquisition was performed in multiple reaction monitoring mode with a positive electrospray ionization source. The mass transitions monitored were m/z 244.1 → 185.3 and m/z 285.2 → 193.2 for agomelatine and internal standard, respectively. The methods were validated for selectivity, carry-over, matrix effects, calibration curves, accuracy and precision, extraction recoveries, dilution integrity and stability. The validated method was successfully applied to a pharmacokinetic study of agomelatine in Chinese volunteers following a single oral dose of 25 mg agomelatine tablet.
authors.affiliation: Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, 100049, China.
authors.forename: Xiaolin
authors.initials: X
authors.lastname: Wang
authors.forename: Dan
authors.initials: D
authors.lastname: Zhang
authors.forename: Man
authors.initials: M
authors.lastname: Liu
authors.forename: Hongna
authors.initials: H
authors.lastname: Zhao
authors.forename: Aihua
authors.initials: A
authors.lastname: Du
authors.forename: Lingjie
authors.initials: L
authors.lastname: Meng
authors.forename: Huichen
authors.initials: H
authors.lastname: Liu
mesh_terms: D000081:Acetamides / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D019540:Area Under Curve; D002853:Chromatography, Liquid / Q000379:methods*; D004355:Drug Stability; D006801:Humans; D059625:Liquid-Liquid Extraction; D008297:Male; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D053719:Tandem Mass Spectrometry / Q000379:methods*; D009281:Naphthalenes
chemical_list: D000081:Acetamides; C084711:agomelatine; D009281:Naphthalenes
keywords: LC-MS/MS; agomelatine; pharmacokinetics; plasma