Premium
Sensitive and selective liquid chromatography–tandem mass spectrometry method for the determination of metoclopramide in human plasma: application to a bioequivalence study
Author(s) -
Inamadugu Jaswanth Kumar,
Damaramadugu Rajasekhar,
Mullangi Ramesh,
Ponneri Venkateswarlu
Publication year - 2010
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.1401
Subject(s) - chromatography , chemistry , metoclopramide , ammonium acetate , bioequivalence , extraction (chemistry) , liquid chromatography–mass spectrometry , elution , mass spectrometry , high performance liquid chromatography , pharmacokinetics , pharmacology , medicine , surgery , vomiting
A simple, sensitive and rapid method has been developed and validated for determination of the metoclopramide (MCP) in 100 μL human plasma. The analytical procedure involves a liquid–liquid extraction method using tramadol as an internal standard (IS). Chromatographic separation was carried out on a HyPURITY ADVANCE column using a mobile phase consisting of acetonitrile and 10 m m ammonium acetate buffer in the ratio of 80:20 (v/v) at a flow rate of 0.3 mL/min. The total run time of analysis was 2.5 min and elution of MCP and IS occurred at 0.9 and 1.3 min, respectively. A linear response function was established for the range of concentrations 0.53–42.07 ng/mL ( r > 0.99). The intra‐ and inter‐day precision values for MCP met the acceptance as per FDA guidelines. MCP was stable in a battery of stability studies viz., bench‐top, auto‐sampler and freeze–thaw cycles. The developed assay method was successfully applied to an oral bioequivalence study in humans. Copyright © 2010 John Wiley & Sons, Ltd.