title: Development and validation of a sensitive liquid chromatography/electrospray tandem mass spectrometry assay for the quantification of olanzapine in human plasma.
abstract: A simple, sensitive and rapid liquid chromatography/electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) method was developed and validated for the quantification of olanzapine, atypical antipsychotic drug, in human plasma using loratadine as internal standard (IS). Following liquid-liquid extraction, the analytes were separated using an isocratic mobile phase on a reverse phase C18 column and analyzed by MS in the multiple reaction monitoring mode using the respective [M+H]+ ions, m/z 313/256 for olanzapine and m/z 383/337 for the IS. The assay exhibited a linear dynamic range of 0.1-30 ng/mL for olanzapine in human plasma. The lower limit of quantification was 100 pg/mL with a relative standard deviation of less than 10%. Acceptable precision and accuracy were obtained for concentrations over the standard curve range. The average absolute recovery of olanzapine from spiked plasma samples was 85.5+/-1.9%. A run time of 2.0 min for each sample made it possible to analyze more than 400 human plasma samples per day. The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability or bioequivalence studies.
authors.affiliation: Biopharmaceutical Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad 500034, India. ramakrishna_nirogi@yahoo.co.in
authors.forename: Ramakrishna V S
authors.initials: RV
authors.lastname: Nirogi
authors.forename: Vishwottam N
authors.initials: VN
authors.lastname: Kandikere
authors.forename: Manoj
authors.initials: M
authors.lastname: Shukla
authors.forename: Koteshwara
authors.initials: K
authors.lastname: Mudigonda
authors.forename: Santosh
authors.initials: S
authors.lastname: Maurya
authors.forename: Ravikumar
authors.initials: R
authors.lastname: Boosi
authors.forename: Anjaneyulu
authors.initials: A
authors.lastname: Yerramilli
mesh_terms: D014150:Antipsychotic Agents / Q000097:blood* / Q000493:pharmacokinetics; D001569:Benzodiazepines / Q000097:blood / Q000493:pharmacokinetics; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006801:Humans; D000077152:Olanzapine; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*
chemical_list: D014150:Antipsychotic Agents; D001569:Benzodiazepines; D000077152:Olanzapine