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Development and validation of a selective and robust LC-MS/MS method for quantifying amlodipine in human plasma
P Massaroti1, L A B Moraes, M A M Marchioretto
1Clinical Pharmacology and Gastroenterology Unit, São Francisco University Medical School, Av. Sao Francisco de Assis 218, 12916-900 Bragança Paulista, SP, Brazil.
Analytical and Bioanalytical Chemistry
|May 14, 2005
Summary
A validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method accurately quantifies amlodipine in human plasma. This robust assay is suitable for analyzing clinical samples, ensuring reliable amlodipine level determination.
Area of Science:
- Analytical Chemistry
- Pharmacokinetics
- Clinical Chemistry
Background:
- Accurate quantification of amlodipine in human plasma is crucial for therapeutic drug monitoring and pharmacokinetic studies.
- Existing methods may require improvement in terms of sensitivity, selectivity, or efficiency.
Purpose of the Study:
- To develop and validate a sensitive and selective liquid chromatographic-tandem mass spectrometric (LC-MS/MS) method for amlodipine quantification in human plasma.
- To establish a reliable analytical tool for amlodipine measurement in clinical settings.
Main Methods:
- Liquid-liquid extraction using NaOH and ethyl acetate/hexane for sample preparation.
- Separation using a C-18 analytical column with optimized mobile phase conditions.
- Detection and quantification via electrospray ionization in positive mode (ESI(+)) and selected reaction monitoring (SRM) on a tandem mass spectrometer.
Main Results:
- The method demonstrated a wide calibration range (0.2–20.0 ng/mL) with excellent linearity.
- High precision and accuracy were achieved, with inter-day relative standard deviation (RSD) and accuracy <15%.
- The developed LC-MS/MS method proved to be robust and stable for analyzing amlodipine in human plasma samples.
Conclusions:
- The developed LC-MS/MS method is accurate, precise, and robust for quantifying amlodipine in human plasma.
- This validated method is suitable for routine clinical analysis and pharmacokinetic investigations of amlodipine.