HPLC STUDIES FOR ASSESSING THE STABILITY OF CARVEDILOL TABLETS
ANNE-MARIE CIOBANU 1#, ANCA LUCIA POP 1#*, SIMONA CRIŞAN 2#, MARIANA PALI 2#, GEORGE TRAIAN ALEXANDRU BURCEA-DRAGOMIROIU 1#, DANIELA ELENA POPA 1#, DUMITRU LUPULIASA 1#, MARIA BÂRCĂ 1#
1.“Carol Davila” University of Medicine and Pharmacy, Faculty of Pharmacy, 6 Traian Vuia Street, Bucharest, Romania
2.“AC HELCOR” Pharmaceutical Company, R&D Centre, 6 Victor Babeş Street, Baia Mare, Romania
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Stability studies evaluate the effect of environmental factors on the quality of the drug product and they are developed to estimate the shelf life and the storage conditions. These studies should be designed following the guidelines issued by ICH, WHO and EMA, and they involve cost and time consumption, but also scientific expertise. All current guidelines recommend that the stability-indicating nature of the analytical procedure should be demonstrated by inclusion of forced degradation studies results in the validation of the procedures, together with chromatograms of the stressed samples. In the current study, two validated stability-indicating HPLC methods were used: one for the assay and one for the related substances. The stability of carvedilol tablets was demonstrated, both in accelerated (6 months) and long term conditions (36 months).