Journal: Journal of Pharmacy Research

Article Id: JPRS-PA-00001320
Title: Application of a novel UPLC-MS/MS method for the pharmacokinetic/bioequivalence determination of atorvastatin and ezetimibe in human plasma
Category: Pharmaceutical Analysis
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    Aims: The aim of this study is to determine the pharmacokinetic parameters of atorvastatin calcium (AT) and ezetimibe (EZ) in human volunteers following the administration of a single oral dose of two drug products containing both active ingredients. Materials and methods: A novel, sensitive and selective ultra performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MS/MS) method was developed and validated for the quantification of AT and EZ in human plasma, following administration of a single dose comprising AT 40 mg and EZ 10 mg, using a non-blind, twotreatment, two-period, randomized, crossover design, in twenty four healthy human volunteers. Atorvastatin, ezetimibe and the internal standard etilefrine (IS) were extracted from plasma and analyzed on a reversed-phase C18 column under gradient conditions. Results: The ion transitions monitored in multiple reaction-monitoring mode were 440.4, 271.25, 164.02 m/z derived from 559.57, 408.43, 182.12 m/z for AT, EZ and IS respectively. Calibration curves were generated over the range of 0.1e20 ng mL1 for both drugs with values for coefficient of correlation greater than 0.999. The parametric point estimates and the 90% confidence intervals for ln-transformed AUC0et, AUC0eN, and cmax, were within commonly accepted bioequivalence range of 80e125% range, thus the results reveal that the bioequivalence between the two drug products could be concluded. Conclusion: The method is very simple and allows obtaining a very good recovery of the analytes. The validated UPLCeMS/MS method has been applied to a pharmacokinetic/ bioequivalence study.

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    Author(s) Name:

    Ghada Abdelbary a,*, Marianne Nebsen b

    Affiliation(s) Name:

    a Pharmaceutics and Industrial Pharmacy Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, Cairo 11562, Egypt
    b Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, Cairo 11562, Egypt

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    Author:

    Ghada Abdelbary a,*, Marianne Nebsen b

    Title:Application of a novel UPLC-MS/MS method for the pharmacokinetic/bioequivalence determination of atorvastatin and ezetimibe in human plasma
    Journal:Journal of Pharmacy Research
    Vol(issue):7 (January )
    Year:2013
    Page No: (24-32)
  • Experimental Methods Keywords

    Methodology:Pharmacokinetic/bioequivalence study, Plasma UPLC-MS/MS
    Research Materials:Atorvastatin, Ezetimibe

Keywords

Atorvastatin Ezetimibe Pharmacokinetic/bioequivalence study Plasma UPLC-MS/MS

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