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Journal article

Validation of a sensitive LC/MS/MS method for simultaneous quantitation of flupentixol and melitracene in human plasma.

Che J, Meng Q, Chen Z, San C, Hou Y, Cheng Y ...see all

Journal of pharmaceutical and biomedical analysis, vol. 45, issue 5 (2007) pp. 785-92

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Abstract

A sensitive method has been developed and validated, using LC/ESI-MS/MS, for simultaneous quantitation of flupentixol and melitracen--antidepressant drugs, in human plasma. The quantitation of the target compounds was determined in a positive ion mode and multiple reaction monitoring (MRM). The method involved a repeated liquid-liquid extraction with diethyl ether and analytes were chromatographed on a C(8) chromatographic column by elution with acetonitrile-water-formic acid (36:64:1, v/v/v) and analyzed by tandem mass spectrometry. The method was validated over the concentration ranges of 26.1-2090 pg/ml for flupentixol and 0.206-4120 ng/ml for melitracen. The correlation coefficients of both analyst were >0.998 for six sets of calibration curves. The recovery was 60.9-75.1% for flupentixol, melitracen and internal standard. The lower limit of quantitation (LLOQ) detection was 26.1 pg/ml for flupentixol and 0.206 ng/ml for melitracen. Intra- and inter-day precision of the assay at three concentrations were 2.15-5.92% with accuracy of 97.6-103.0% for flupentixol and 0.5-6.36% with accuracy of 98.7-101.7% for melitracen. Stability of compounds was established in a battery of stability studies, i.e., bench-top, autosampler and long-term storage stability as well as freeze/thaw cycles. The method proved to be suitable for bioequivalence study of flupentixol and melitracen in healthy human male volunteers.

Author-supplied keywords

  • Anthracenes
  • Anthracenes: analysis
  • Anthracenes: chemistry
  • Anthracenes: pharmacokinetics
  • Antipsychotic Agents
  • Antipsychotic Agents: blood
  • Antipsychotic Agents: chemistry
  • Antipsychotic Agents: pharmacokinetics
  • Calibration
  • Chromatography, Liquid
  • Chromatography, Liquid: methods
  • Drug Stability
  • Flupenthixol
  • Flupenthixol: blood
  • Flupenthixol: chemistry
  • Flupenthixol: pharmacokinetics
  • Freezing
  • Humans
  • Male
  • Molecular Structure
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Spectrometry, Mass, Electrospray Ionization
  • Tandem Mass Spectrometry
  • Tandem Mass Spectrometry: methods
  • Temperature
  • Therapeutic Equivalency

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Authors

  • Jinjing Che

  • Qingfang Meng

  • Zhihang Chen

  • Chengqi San

  • Yunan Hou

  • Yuanguo Cheng

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