HPLC STUDIES FOR ASSESSING THE STABILITY OF CARVEDILOL
TABLETS
ANNE-MARIE CIOBANU1#, ANCA LUCIA POP1#*, SIMONA CRIŞAN2#, MARIANA PALI2#, GEORGE TRAIAN ALEXANDRU BURCEA-DRAGOMIROIU1#, DANIELA ELENA POPA1#, DUMITRU LUPULIASA1#, MARIA BÂRCĂ1#
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
*corresponding author: anca.pop@umfcd.ro
# All authors have equal contribution.
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Abstract:
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).

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