Romanian Society of Pharmaceutical Sciences
 

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SIMULTANEOUS DETERMINATION OF AMLODIPINE AND ATORVASTATIN BY CAPILLARY ELECTROPHORESIS FROM FIXED PHARMACEUTICAL FORMULATIONS

ELEONORA MIRCIA1, TEODORA BALACI2*, GABRIEL HANCU3, VALENTIN ION4, ANCA CÂRJE4

1.Department of Organic Chemistry, Faculty of Pharmacy, University of Medicine and Pharmacy, Tîrgu Mureş, Romania
2.Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy, University of Medicine and Pharmacy “Carol Davila”, Bucharest, Romania
3.Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Medicine and Pharmacy, Tîrgu Mureş, Romania
4.Department of Drug Analysis and Analytical Chemistry, Faculty of Pharmacy, University of Medicine and Pharmacy, Tîrgu Mureş, Romania

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Optimum blood pressure levels through monotherapy may be challenging, especially for patients affected concomitantly by several illnesses. Consequently, fixed-dose which combines several active agents in single pharmaceutical formulations appears to be a golden standard in overcoming the cardiovascular disease. One of these fixed-dose combinations is dihydropyridine calcium channel antagonist amlodipine and the 3-hydroxy-3-methyl-glutaryl-CoA (HMG-CoA) reductase inhibitor atorvastatin, which manage two important risk factors simultaneously in patients exposed to the cardiovascular disease and concomitant hypertension and dyslipidaemia. This study presents the development and validation of a simple, rapid, cost-effective capillary electrophoresis method for the simultaneous determination of amlodipine and atorvastatin in tablet formulations. The best results were obtained when using a 50 mM phosphate buffer at a pH of 7.0, the substances being detected in less than 5 minutes, the order of migration being amlodipine, followed by atorvastatin. The optimization of the electrophoretic conditions was based on obtaining improved peak shape, resolution and separation time. The analytical performances of the method were verified by quantifying specific parameters such as linearity, limit of detection, limit of quantitation, precision, accuracy, robustness and selectivity. The applicability of the method was verified by assessing amlodipine and atorvastatin from the original pharmaceutical product Caduet®.