title: Method development, validation and bioequivalence of varenicline in human plasma by liquid chromatography tandem mass spectrometry.
abstract: A method based on liquid chromatography coupled to tandem mass spectrometry was developed for quantitative determination of varenicline in human plasma. Varenicline and the internal standard (25.0ng/mL of Clarithromycin) were extracted from human plasma by liquid-liquid extraction, using methyl tertiary butyl ether as the organic solvent. The chromatographic separation was achieved using C8 column with isocratic elution using a mixture of acetonitrile:0.001M ammonium acetate (adjusted to pH 4.0) (70:30%, v/v). The method was validated over the concentration range of 0.1-10.0ng/mL by investigating specificity, sensitivity, linearity, precision, accuracy, recovery, matrix effect and stability according to United State Food and Drug Administration guideline. The validated bioanalytical method was successfully applied to evaluate bioequivalence of two commercial products of 1mg varenicline single dose.
authors.affiliation: University of Jordan, Chemistry Department, P.O. Box 13003, Amman 11942, Jordan. ajmasg150@hotmail.com
authors.forename: Ayoub
authors.initials: A
authors.lastname: Al-Haj
authors.forename: Mahmoud
authors.initials: M
authors.lastname: Alawi
authors.forename: Tawfiq
authors.initials: T
authors.lastname: Arafat
authors.forename: Mohammad Khair
authors.initials: MK
authors.lastname: Hourani
mesh_terms: D001552:Benzazepines / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D002853:Chromatography, Liquid / Q000379:methods*; D017291:Clarithromycin / Q000097:blood; D006801:Humans; D016014:Linear Models; D011810:Quinoxalines / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013810:Therapeutic Equivalency; D000068580:Varenicline
chemical_list: D001552:Benzazepines; D011810:Quinoxalines; D017291:Clarithromycin; D000068580:Varenicline