ACCELERATED STABILITY TESTING OF IBUPROFEN-EUDRAGIT RSPM SUSTAINED RELEASE TABLETS USING 1H-NMR, HPLC AND TLC

Abdel Rahman, Aly A.; Aboutaleb, A. E.; Stamm, A.; Abdel Rahman, S. I.; Samy, E. M.

doi:10.21608/bfsa.1993.70021

ACCELERATED STABILITY TESTING OF IBUPROFEN-EUDRAGIT RSPM SUSTAINED RELEASE TABLETS USING 1H-NMR, HPLC AND TLC

Document Type : Original Article

Authors

¹ Department of Industrial Pharmacy, Faculty of Pharmacy, Assiut University, Assiut, Egypt

² Faculty of Pharmacy, Louis Pasteur University, France

10.21608/bfsa.1993.70021

Abstract

Ibuprofen-Eudragit RSPM sustained release tablets, already have been formulated, were subjected to accelerated stability testing for 6 months at 25, 37 and 45°C.The tablets were stored in firmly closed glass bottles in order to eliminate the effect of humidity, a condition simulating the actual shelf storage.
The drug content of the stored tablets was evaluated using ¹H-NMR, HPLC and TLC techniques in order to investigate the effect of temperature on ibuprofen stability.
A small reduction (2-4 % w/w) in the drug content was detected in the tablets stored at 37 and 45°C for 6 months using ¹H-NMR and HPLC techniques. The decomposition of ibuprofen in the preformulated tablets was found to be first order reaction kinetics.
It was concluded that the expiry date of ibuprofen in the formulated sustained release tablets is up to 3 years. Thus this formulation could be considered as a convenient pharmaceutical formulation of ibuprofen.