Determination of lercanidipine in human plasma by an improved UPLC-MS/MS method for a bioequivalence study.

Journal: Journal of pharmaceutical analysis
Published Date: Sep 28, 2015

Abstract

An improved and reliable ultra-performance liquid chromatography/tandem mass spectrometry (UPLC-MS/MS) method has been developed and validated for the determination of lercanidipine in human plasma. Plasma samples with lercanidipine-d3 as an internal standard (IS) were prepared by solid phase extraction on Phenomenex Strata-X cartridges using 100 µL of human plasma. Chromatographic analysis was performed on UPLC BEH C (50 mm×2.1 mm, 1.7 µm) column under isocratic conditions. Linear calibration curves were obtained over a wide dynamic concentration range of 0.010-20.0 ng/mL. Matrix effect was assessed by post-column infusion, post-extraction spiking and standard-line slope methods. The mean extraction recovery was >94% for the analyte and IS. Inter-batch and intra-batch precision (% CV) across five quality controls was <5.8%. Bioequivalence study was performed with 36 healthy subjects after oral administration of 10 mg of lercanidipine and the assay reproducibility was evaluated by reanalysis of 133 incurred samples.

Authors

  • Darshan V Chaudhary
    Department of Chemistry, School of Sciences, Gujarat University, Navrangpura, Ahmedabad, Gujarat 380009, India.
  • Daxesh P Patel
    Laboratory of Metabolism, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Building 37, Room 3106, Bethesda, MD 20892, USA.
  • Priyanka A Shah
    Department of Chemistry, School of Sciences, Gujarat University, Ahmedabad, 380009, India.
  • Jaivik V Shah
    Department of Chemistry, School of Sciences, Gujarat University, Ahmedabad 380009, India.
  • Mallika Sanyal
    Kadi Sarva Viswavidyalaya, Sector-15, Ghandhinagar 382715, Gujarat, India.
  • Pranav S Shrivastav
    Department of Chemistry, School of Sciences, Gujarat University, Ahmedabad, 380009, India.

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