Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume 45,
Number 2, February 2007, pp.97-103
Quantitative Determination of Galantamine in Human
Plasma by Sensitive Liquid Chromatography–Tandem Mass Spectrometry
Using Loratadine as an Internal Standard
Ramakrishna V.S. Nirogi, Vishwottam N. Kandikere,
Koteshwara Mudigonda, and Santosh Maurya
Biopharmaceutical Research, Suven Life Sciences Ltd, Serene Chambers,
Road # 7, Banjara Hills, Hyderabad 500034, India
A simple, rapid, sensitive, and selective liquid
chromatography– tandem mass spectrometry method is developed
and validated for the quantitation of galantamine, an acetylcholinesterase
inhibitor in human plasma, using a commercially available compound,
loratadine, as the internal standard. Following liquid–liquid
extraction, the analytes are separated using an isocratic mobile
phase on a reverse-phase C18 column and analyzed by mass spectrometry
in the multiple reaction monitoring mode using the respective
(M+H)+ ions, m/z 288 to 213 for galantamine and m/z 383 and 337
for the internal standard. The assay exhibit a linear dynamic
range of 0.5–100 ng/mL for galantamine in human plasma.
The lower limit of quantitation is 0.5 ng/mL, with a relative
standard deviation of less than 8%. Acceptable precision and accuracy
are obtained for concentrations over the standard curve range.
A run time of 2.5 min for each sample makes it possible to analyze
more than 400 human plasma samples per day. The validated method
is successfully used to analyze human plasma samples for application
in pharmacokinetic, bioavailability, or bioequivalence studies.
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