title: Novel LC- ESI-MS/MS method for desvenlafaxine estimation human plasma: application to pharmacokinetic study.
abstract: A simple, sensitive and specific liquid chromatography tandem mass spectrometry (LC-ESI-MS/MS) method was developed for the quantification of desvenlafaxine in human plasma using desvenlafaxine d6 as an internal standard (IS). Chromatographic separation was performed using a Thermo-BDS hypersil C8 column (50 × 4.6 mm, 3 µm) with an isocratic mobile phase composed of 5 mM ammonium acetate buffer: methanol (20:80, v/v), at a flow rate of 0.80 mL/min. Desvenlafaxine and desvenlafaxine d6 were detected with proton adducts at m/z 264.2/58.1 and 270.2/ 64.1 in multiple reaction monitoring positive mode, respectively. Liquid-liquid extraction was used to extract the drug and the IS. The method was linear over the concentration range 1.001-400.352 ng/mL with a correlation coefficient of ≥0.9994. This method demonstrated intra and inter-day precision within 0.7-5.5 and 1.9-6.8%, and accuracy within 95.3-107.4 and 93.4-99.5%. Desvenlafaxine was found to be stable throughout the freeze-thaw cycles, bench-top and long-term matrix stability studies. The developed and validated method can be successfully applied for the bioequivalence/pharmacokinetic studies of desvenlafaxine in pharmaceutical dosage forms.
authors.affiliation: University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, India.
authors.forename: Pushpa Kumari
authors.initials: PK
authors.lastname: Kancharla
authors.affiliation: University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, India.
authors.forename: Venu Gopal Raju
authors.initials: VG
authors.lastname: Kondru
authors.affiliation: University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, India.
authors.forename: Gowri Sankar
authors.initials: GS
authors.lastname: Dannana
mesh_terms: D002853:Chromatography, Liquid / Q000379:methods*; D000069468:Desvenlafaxine Succinate / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics*; D004355:Drug Stability; D006801:Humans; D016014:Linear Models; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D000069468:Desvenlafaxine Succinate
keywords: Desvenlafaxine; LC- ESI- MS/MS; Liquid-liquid extraction; bioequivalence; human plasma; pharmacokinetics