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A bio-analytical hydrophilic interaction LC-MS/MS method for the simultaneous quantification of omeprazole and lansoprazole in human plasma in support of a pharmacokinetic omeprazole study in children

Julie De Smet (UGent) , Koen Boussery (UGent) , Pieter De Cock (UGent) , Peter De Paepe (UGent) , Jean Paul Remon (UGent) , Myriam Van Winckel (UGent) and Jan Van Bocxlaer (UGent)
(2010) JOURNAL OF SEPARATION SCIENCE. 33(6-7). p.939-947
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Abstract
A hydrophilic interaction LC method with MS/MS was developed and validated for the simultaneous quantification of omeprazole and lansoprazole in human plasma. Chromatographic separation was achieved on a Betasil silica column using a high organic mobile phase (eluent A: ACN/formic acid 997.5:2.5 v/v; eluent B: water/formic acid 997.5:2.5 v/v) and gradient elution. The mass spectrometer was operated in the Multiple Reaction Monitoring mode. Prior to chromatography, liquid-liquid extraction with ethyl acetate was used and the organic layer was diluted with ACN, allowing direct injection on column. The method showed acceptable linearity, high precision (RSD%<10.5%), accuracy (88.9-109.3%) and selectivity in the two concentration ranges studied: 1.5-100 and 5-2000 ng/mL. The LOQ was established at 1.5 and 5 ng/mL for the two concentration ranges. Lack of variability in matrix effects was demonstrated and mean extraction recovery for omeprazole and lansoprazole was determined in the low (56.3-67.7%) and high (45.3-44.3%) concentration range, respectively. Additionally, plasma samples were found to be stable after three freeze-thaw cycles and for at least 15 h after extraction. This assay was successfully applied to a pharmacokinetic omeprazole study in children with cerebral palsy and mental retardation.
Keywords
PERFORMANCE LIQUID-CHROMATOGRAPHY, PROTON PUMP INHIBITORS, HPLC, TANDEM MASS-SPECTROMETRY, Quantification, Proton pump inhibitor, Omeprazole, Lansoprazole, SOLID-PHASE EXTRACTION, Hydrophilic interaction LC, METABOLITES, BLOOD-PLASMA, PANTOPRAZOLE, COLUMN, SINGLE

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Chicago
De Smet, Julie, Koen Boussery, Pieter De Cock, Peter De Paepe, Jean Paul Remon, Myriam Van Winckel, and Jan Van Bocxlaer. 2010. “A Bio-analytical Hydrophilic Interaction LC-MS/MS Method for the Simultaneous Quantification of Omeprazole and Lansoprazole in Human Plasma in Support of a Pharmacokinetic Omeprazole Study in Children.” Journal of Separation Science 33 (6-7): 939–947.
APA
De Smet, Julie, Boussery, K., De Cock, P., De Paepe, P., Remon, J. P., Van Winckel, M., & Van Bocxlaer, J. (2010). A bio-analytical hydrophilic interaction LC-MS/MS method for the simultaneous quantification of omeprazole and lansoprazole in human plasma in support of a pharmacokinetic omeprazole study in children. JOURNAL OF SEPARATION SCIENCE, 33(6-7), 939–947.
Vancouver
1.
De Smet J, Boussery K, De Cock P, De Paepe P, Remon JP, Van Winckel M, et al. A bio-analytical hydrophilic interaction LC-MS/MS method for the simultaneous quantification of omeprazole and lansoprazole in human plasma in support of a pharmacokinetic omeprazole study in children. JOURNAL OF SEPARATION SCIENCE. 2010;33(6-7):939–47.
MLA
De Smet, Julie, Koen Boussery, Pieter De Cock, et al. “A Bio-analytical Hydrophilic Interaction LC-MS/MS Method for the Simultaneous Quantification of Omeprazole and Lansoprazole in Human Plasma in Support of a Pharmacokinetic Omeprazole Study in Children.” JOURNAL OF SEPARATION SCIENCE 33.6-7 (2010): 939–947. Print.
@article{986003,
  abstract     = {A hydrophilic interaction LC method with MS/MS was developed and validated for the simultaneous quantification of omeprazole and lansoprazole in human plasma. Chromatographic separation was achieved on a Betasil silica column using a high organic mobile phase (eluent A: ACN/formic acid 997.5:2.5 v/v; eluent B: water/formic acid 997.5:2.5 v/v) and gradient elution. The mass spectrometer was operated in the Multiple Reaction Monitoring mode. Prior to chromatography, liquid-liquid extraction with ethyl acetate was used and the organic layer was diluted with ACN, allowing direct injection on column. The method showed acceptable linearity, high precision (RSD\%{\textlangle}10.5\%), accuracy (88.9-109.3\%) and selectivity in the two concentration ranges studied: 1.5-100 and 5-2000 ng/mL. The LOQ was established at 1.5 and 5 ng/mL for the two concentration ranges. Lack of variability in matrix effects was demonstrated and mean extraction recovery for omeprazole and lansoprazole was determined in the low (56.3-67.7\%) and high (45.3-44.3\%) concentration range, respectively. Additionally, plasma samples were found to be stable after three freeze-thaw cycles and for at least 15 h after extraction. This assay was successfully applied to a pharmacokinetic omeprazole study in children with cerebral palsy and mental retardation.},
  author       = {De Smet, Julie and Boussery, Koen and De Cock, Pieter and De Paepe, Peter and Remon, Jean Paul and Van Winckel, Myriam and Van Bocxlaer, Jan},
  issn         = {1615-9306},
  journal      = {JOURNAL OF SEPARATION SCIENCE},
  keyword      = {PERFORMANCE LIQUID-CHROMATOGRAPHY,PROTON PUMP INHIBITORS,HPLC,TANDEM MASS-SPECTROMETRY,Quantification,Proton pump inhibitor,Omeprazole,Lansoprazole,SOLID-PHASE EXTRACTION,Hydrophilic interaction LC,METABOLITES,BLOOD-PLASMA,PANTOPRAZOLE,COLUMN,SINGLE},
  language     = {eng},
  number       = {6-7},
  pages        = {939--947},
  title        = {A bio-analytical hydrophilic interaction LC-MS/MS method for the simultaneous quantification of omeprazole and lansoprazole in human plasma in support of a pharmacokinetic omeprazole study in children},
  url          = {http://dx.doi.org/10.1002/jssc.200900590},
  volume       = {33},
  year         = {2010},
}

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