A Quick and Sensitive Liquid Chromatography-Tandem Mass Spectrometry (LC-MS) Method for the Evaluation of Two Formulations of Amlodipine and Atorvastatin in Healthy Male Volunteers

Abstract

An open-label, single-dose, randomized, 2-way crossover study was conducted in fasted healthy Iranian male volunteers. Eligible participants randomly assigned in a 1:1 ratio to be given one tablet of the test or reference formulation, followed by a 2-week washout period and administration of the exchange formulation. A quick and susceptible Liquid Chromatography–tandem Mass Spectrometry (LC-MS) method for the evaluation of amlodipine and atorvastatin in tablets.Revealing of analysts was achieved by tandem mass spectrometry with ElectroSpray Ionization (ESI) interface in positive ion mode was operated under the multiple-reaction monitoring mode. The assay results ascertain the presence and compendia quality of amlodipine and atorvastatin in all these products. The validation tests on the developed method indicated an acceptable degree of linearity, sensitivity, precision, accuracy and recovery for the method. The intra-day and inter-day precision and accuracy results were well within the acceptable limits. The method is rapid, simple, very stable and specific for the partition, assignment, evaluation of amlodipine and atorvastatin healthy Iranian adult male volunteers.

Keywords

• amlodipine
• atorvastatin
• lc-ms
• tablets
• male volunteers