This paper describes a selective and sensitive assay for the determination of olanzapine(OLZ)in human plasma based on liquid chromatography-tandem mass spectrometry(LC-MS/MS).The analyte and quetiapine as internal sta...This paper describes a selective and sensitive assay for the determination of olanzapine(OLZ)in human plasma based on liquid chromatography-tandem mass spectrometry(LC-MS/MS).The analyte and quetiapine as internal standard(IS)were extracted from 200μL plasma via solid phase extraction on Waters Oasis HLB cartridges.Chromatographic separation was achieved on an ACE 5C18-300 column(100 mm × 4.6 mm,5μm)under isocratic conditions in a run time of 3.5 min.Mass spectrometric detection involved electrospray ionization in the positive ion mode followed by multiple reaction monitoring(MRM)of the transitions at m/z 313/256 for OLZ and m/z 384/253 for the IS.The assay was linear in the range 0.10-40.0 ng/mL with a lower limit of quantitation and limit of detection of 0.10 and 0.012 ng/mL,respectively.Intra-and inter-day precision(as coefficient of variation)and relative recovery were<5.0% and>90%,respectively.The method was succesfully applied to a bioequivalence study of 5 and 10 mg OLZ disintegrating tablets in 40 healthy Indian males with reproducibility by incurred sample reanalysis in the range-7.43 to 8.07%.展开更多
文摘This paper describes a selective and sensitive assay for the determination of olanzapine(OLZ)in human plasma based on liquid chromatography-tandem mass spectrometry(LC-MS/MS).The analyte and quetiapine as internal standard(IS)were extracted from 200μL plasma via solid phase extraction on Waters Oasis HLB cartridges.Chromatographic separation was achieved on an ACE 5C18-300 column(100 mm × 4.6 mm,5μm)under isocratic conditions in a run time of 3.5 min.Mass spectrometric detection involved electrospray ionization in the positive ion mode followed by multiple reaction monitoring(MRM)of the transitions at m/z 313/256 for OLZ and m/z 384/253 for the IS.The assay was linear in the range 0.10-40.0 ng/mL with a lower limit of quantitation and limit of detection of 0.10 and 0.012 ng/mL,respectively.Intra-and inter-day precision(as coefficient of variation)and relative recovery were<5.0% and>90%,respectively.The method was succesfully applied to a bioequivalence study of 5 and 10 mg OLZ disintegrating tablets in 40 healthy Indian males with reproducibility by incurred sample reanalysis in the range-7.43 to 8.07%.
