Premium
Sensitive and rapid liquid chromatography/tandem mass spectrometry assay for the quantification of amlodipine in human plasma
Author(s) -
Nirogi Ramakrishna V. S.,
Kandikere Vishwottam N.,
Mudigonda Koteshwara,
Shukla Manoj,
Maurya Santosh
Publication year - 2006
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.600
Subject(s) - chromatography , chemistry , amlodipine , bioequivalence , electrospray ionization , analyte , pharmacokinetics , extraction (chemistry) , liquid chromatography–mass spectrometry , detection limit , tandem mass spectrometry , mass spectrometry , selected reaction monitoring , bioavailability , high performance liquid chromatography , standard curve , pharmacology , blood pressure , medicine , radiology
A simple, sensitive and rapid high‐performance liquid chromatography/electrospray ionization tandem mass spectrometry method was developed and validated for the assay of amlodipine in human plasma. Following liquid–liquid extraction, the analytes were separated using an isocratic mobile phase on a reverse‐phase C 18 column and analyzed by MS in the multiple reaction monitoring mode using the respective [M+H] + ions, m/z 409/238 for amlodipine and m/z 409/228 for the IS. The assay exhibited a linear dynamic range of 50–10,000 pg/mL for amlodipine in human plasma. The lower limit of quantification was 50 pg/mL with a relative standard deviation of less than 8%. Acceptable precision and accuracy were obtained for concentrations over the standard curve range. The average absolute recoveries of amlodipine and the IS from spiked plasma samples were 74.7 ± 4.6 and 72.1 ± 2.0%, respectively. A run time of 1.5 min for each sample made it possible to analyze more than 400 human plasma samples per day. The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability or bioequivalence studies. The observed maximum plasma concentration ( C max ) of amlodipine (2.5 mg oral dose) was 1425 pg/mL, time to observed maximum plasma concentration ( T max ) was 8.1 h and elimination half‐life ( T 1/2 ) was 50.1 h. Copyright © 2006 John Wiley & Sons, Ltd.