Method validation of amlodipine and atorvastatin by liquid chromatography–mass spectrometry (LC–MS) method in human plasma

Abstract

A rapid and selective liquid chromatography–mass spectrometry (LC–MS) method was developed for the evaluation of amlodipine and atorvastatin in human plasma. Detection of analytes was assigned by tandem mass spectrometry with electrospray ionization interface in positive ion mode was applied under the multiple-reaction monitoring mode (MRM). Analytes were extracted from plasma by simple liquid–liquid extraction technique using ethyl acetate. The reconstituted samples were chromatographed on C₁₈ column by pumping acetonitrile–water (10 mM CH₃COONH₄, pH 3.0) = 70:30 (v/v) at a flow rate of 0.15 mL/min. The standard curves were assigned to be linear in the range of 0.2–20 ng/mL for atorvastatin and 0.1–10 ng/mL for amlodipine with mean correlation coefficient of ≥0.999 for each analyte. The intra-day and inter-day precision and accuracy results were well within the acceptable limits. The urbanized evaluate method was successfully applied to validation of amlodipine and atorvastatin in human plasma.

Keywords:

• amlodipine
• atorvastatin
• LC–MS
• human plasma

Public Interest Statement

A susceptible, discriminating, perfect and specific liquid chromatography–mass spectrometry (LC–MS) method with SIM by single quadruple mass spectrometer with ESI interface in positive ion mode with NRM mode was urbanized and assigned for evaluation of amlodipine and atorvastatin in human plasma. The intra-day and inter-day precision and accuracy results were well within the acceptable limits. The valuated method offers several compensations such as a quick and easy extraction scheme, and a short chromatographic run time, which makes the method possible for the analysis of large sample batches resulting from assay of amlodipine and atorvastatin in human plasma.

Competing interests

The authors declare no competing interest.

Additional information

Funding

Funding. This work has been financially supported by the Faculty of Pharmacy, Zanjan University of Medical Sciences.

Notes on contributors

Hossein Danafar

Dr. Hossein Danafar is Assistant Professor of Medicinal Chemistry and Dean of Department of Medicinal Chemistry at the School of Pharmacy, Zanjan University of Medical Sciences, Zanjan, Iran. He received his PhD (2013) degree in Medicinal Chemistry from Tabriz University of Medical Sciences, Tabriz, Iran. His current research interests are the analytical chemistry, pharmaceutical analysis, design, synthesis and characterization of polymeric drug delivery systems, including micelles, nanogels and molecularly imprinted carriers, bioconjugates, and magnetic targeted drug delivery systems. The future study is analysis of other formulation drugs by HPLC, LC–MS, and GC-MS in human plasma.