title: Validated LC-MS/MS method for quantification of agomelatine in human plasma and its application in a pharmacokinetic study.
abstract: An analytical method based on liquid-liquid extraction has been developed and validated for analysis of agomelatine in human plasma. Fluoxetine was used as an internal standard for agomelatine. A Betasil C18 (4.0 × 100 mm, 5 µm) column provided chromatographic separation of analytes followed by detection with mass spectrometry. The method involves simple isocratic chromatographic conditions and mass spectrometric detection in the positive ionization mode using an API-4000 system. The proposed method has been validated with linear range of 0.050-8.000 ng/ml for agomelatine. The intra-run and inter-run precision values are within 12.12% and 9.01%, respectively, for agomelatine at the lower limit of quantification level. The overall recovery for agomelatine and fluoxetine was 67.10% and 72.96%, respectively. This validated method was used successfully for analysis of plasma samples from a pharmacokinetic study.
authors.affiliation: Department of pharmacology, SVKMS NMIMS University, Vile Parle (W), Mumbai, 400056, India.
authors.forename: Satish R
authors.initials: SR
authors.lastname: Patil
authors.forename: Ketan K
authors.initials: KK
authors.lastname: Nerurkar
authors.forename: Ashok M
authors.initials: AM
authors.lastname: Kalamkar
authors.forename: Vishwas
authors.initials: V
authors.lastname: Pukale
authors.forename: Kiran V
authors.initials: KV
authors.lastname: Mangaonkar
authors.forename: Satish G
authors.initials: SG
authors.lastname: Pingale
mesh_terms: D000081:Acetamides / Q000097:blood* / Q000493:pharmacokinetics; D019540:Area Under Curve; D002853:Chromatography, Liquid / Q000379:methods*; D005473:Fluoxetine; D006801:Humans; D016018:Least-Squares Analysis; D059625:Liquid-Liquid Extraction; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D053719:Tandem Mass Spectrometry / Q000379:methods*; D009281:Naphthalenes
chemical_list: D000081:Acetamides; D005473:Fluoxetine; C084711:agomelatine; D009281:Naphthalenes