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Current Pharmaceutical Analysis
ISSN (Print): 1573-4129
ISSN (Online): 1875-676X
VOLUME: 8
ISSUE: 3
DOI: 10.2174/157341212801619351      Price:  $58









Liquid Chromatography-Mass Spectrometry Method for the Determination of Olanzapine in Human Plasma and Application to a Bioequivalence Study

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Author(s): Jing Cao, Zunjian Zhang, Yuan Tian, Yuanyuan Li and Jianzhong Rui
Pages 247-254 (8)
Abstract:
A rapid, sensitive and selective liquid chromatography-mass spectrometry (LC-MS) method was developed and validated for the identification and determination of olanzapine (OLZ, CAS 132539-06-1) in human plasma. Following liquid- liquid extraction, OLZ and loratadine (IS, CAS 79794-75-5) were separated using a mobile phase consisting of acetonitrile: aqueous ammonium acetate solution (pH 4.0, 10 mM) = 56:44 (v/v) on an Agilent ZORBAX Eclipse XDB-CN (2.1mmx150mm I.D., 5μm) column and analyzed by electrospray ionization mass spectrometry in the selected ion monitoring (SIM) mode using the respective [M+H]+ ions, m/z 313.15 for OLZ and m/z 383.00 for loratadine. The chromatographic separation was achieved in less than 6.0 min. The assay exhibited a linear dynamic range of 0.5–50 ng/ml for OLZ in human plasma and had good accuracy and precision. Both intra- and inter-batch standard deviations were less than 15%. The validated LC–MS method was first applied to a bioequivalence study in 20 healthy male Chinese volunteers.
Keywords:
Application, Bioequivalence, Chinese volunteers, Determination, Identification, Human plasma, LC-MS, Loratadine, Olanzapine, Pharmacokinetics
Affiliation:
Center for Instrumental Analysis, China Pharmaceutical University, 24 Tongjia Lane, Nanjing 210009 (P.R. China).