Format

Send to:

Choose Destination
See comment in PubMed Commons below
Biomed Chromatogr. 2013 Sep;27(9):1192-9. doi: 10.1002/bmc.2926. Epub 2013 May 3.

Rapid quantification of amlodipine enantiomers in human plasma by LC-MS/MS: application to a clinical pharmacokinetic study.

Author information

  • 1Analytical Research and Development, Novel Laboratories Inc., Somerset, NJ 08873, USA.

Abstract

A rapid, simple, specific and sensitive LC-MS/MS method has been developed and validated for the enantiomeric quantification of amlodipine (AML) isomers [R-amlodipine (R-AML) and S-amlodipine (S-AML)] with 200 μL of human plasma using R-AML-d4 and S-AML-d4 as corresponding internal standards as per regulatory guidelines. A simple liquid-liquid extraction process was used to extract these analytes from human plasma. The total run time was 3.5 min and the elution of R-AML, S-AML, R-AML-d4 and S-AML-d4 occurred at 1.62, 2.51, 1.63 and 2.53 min, respectively. This was achieved with a mobile phase consisting of 0.2% ammonia-acetonitrile (20:80, v/v) at a flow rate of 1 mL/min on a Chiralcel OJ RH column. A linear response function was established for the range of concentrations 0.1-10 ng/mL (r >0.998) for each enantiomer. The intra- and inter-day precision values for both enantiomers met the acceptance criteria. Both enantiomers were stable in a set of stability studies, viz. bench-top, auto-sampler, freeze-thaw cycles and long-term. The current assay was successfully applied to a pharmacokinetic study to quantitate AML enantiomers following oral administration of 10 mg AML tablet to humans.

Copyright © 2013 John Wiley & Sons, Ltd.

KEYWORDS:

LC-MS/MS; amlodipine; enantiomers; human plasma; method validation; pharmacokinetics

PMID:
23640924
[PubMed - indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for John Wiley & Sons, Inc.
    Loading ...
    Write to the Help Desk