Determination Of Amlodipine In Human Plasma By Liquid Chromatography–tandem Mass Spectrometry And Its Application To Pharmacokinetic & Bioequivalence Studies | 34536
Journal of Analytical & Bioanalytical Techniques
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A rapid Liquid Chromatographic-Tandem Mass Spectrometric (LC-MS/MS) assay for the measurement of amlodipine level in
human plasma was developed and validated. Amlodipine and tizanidine (IS) were extracted from plasma using mixture of
dichloromethane and tertiary butyl methyl ether (1:3, v:v) and reconstituted with 100 μl mixture of methanol and water (1:1, v:v).
The mobile phase consisted of acetonitrile and 0.1% formic acid (80:20, v:v). Analysis was performed at room temperature using
a reversed phase Atlantis dC18 (2.1x100 mm, 3 μm) column. The components of interest were detected in the positive ion mode
of electrospray ionization using transition 409.8 → 238.4 and 254.3 → 43.9 for amlodipine and the IS, respectively. The relationship
between amlodipine concentration in plasma and peak height ratio of amlodipine to IS was linear ≥0.9868 in the range of 0.2–20 ng/
ml; intra and inter-day accuracy between 101-114%, and coefficient of variations were ≤14.4%. The quantification limit of amlodipine
in 0.5 ml plasma was 0.2 ng/ml and the detection limit was 0.1 ng/ml. The method was successfully validated and applied in a
bioequivalence study of four tablet formulations of amlodipine.
Syed N Alvi obtained his PhD in Chemistry from Osmania University, Hyderabad, India in 2001. He is currently Scientist at King Faisal Specialist Hospital & Research Centre, Riyadh, Saudi Arabia. He his research interest includes method development and validation and application for pharmacokinetic and bioequivalence studies.