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Sensitive method for the determination of paricalcitol by liquid chromatography and mass spectrometry and its application to a clinical pharmacokinetic study
Author(s) -
Hotha Kishore Kumar,
Mullangi Ramesh,
Lakshmanarao Krishnarao Ravindranath,
Roychowdhury Swapan
Publication year - 2015
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.3296
Subject(s) - chromatography , chemistry , analyte , paricalcitol , pharmacokinetics , human plasma , extraction (chemistry) , mass spectrometry , liquid chromatography–mass spectrometry , pharmacology , calcium , parathyroid hormone , medicine , organic chemistry , secondary hyperparathyroidism
A highly sensitive, specific and rapid LC‐ESI‐MS/MS method has been developed and validated for the quantification of paricalcitol (PAR) in human plasma (500 μL) using paricalcitol‐ d 6 (PAR‐ d 6 ) as an internal standard (IS) as per regulatory guidelines. A liquid–liquid extraction method was used to extract the analyte and IS from human plasma. Chromatography was achieved on Zorbax SB C 18 column using an isocratic mobile phase in a gradient flow. The total chromatographic run time was 6.0 min and the elution of PAR and PAR‐ d 6 occurred at ~2.6 min. A linear response function was established for the range of concentrations 10–500 pg/mL in human plasma. The intra‐ and inter‐day accuracy and precision values for PAR met the acceptance criteria. The validated assay was applied to quantitate PAR concentrations in human plasma following oral administration of 4 µg capsules to humans. Copyright © 2014 John Wiley & Sons, Ltd.