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

<em>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. </em><em>A quick and susceptible Liquid Chromatography–tandem Mass Spectrometry (LC-MS) method for the evaluation of amlodipine and atorvastatin in tablets.</em><em>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. </em><em>The assay results ascertain the presence and compendia quality of </em><em>amlodipine and atorvastatin</em><em> 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. </em><em>The intra-day and inter-day precision and accuracy results were well within the acceptable limits. </em>The method is rapid, simple, very stable and specific for the partition, assignment, evaluation of amlodipine<em> and atorvastatin</em><em> healthy Iranian adult male volunteers.</em>