determination of lercanidipine in human plasma by an improved uplc–ms/ms method for a bioequivalence study
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ID: 219104
2016
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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 C18 (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.
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| Reference Key |
chaudhary2016journaldetermination
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|---|---|
| Authors | ;Darshan V. Chaudhary;Daxesh P. Patel;Priyanka A. Shah;Jaivik V. Shah;Mallika Sanyal;Pranav S. Shrivastav |
| Journal | Frontiers in plant science |
| Year | 2016 |
| DOI |
10.1016/j.jpha.2015.09.001
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| URL | |
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