STABILITY ASSESSMENT OF BISOPROLOL FUMARATE UNDER DIFFERENT STRESS CONDITIONS

*Abdullah Ali Yahya AL-Asali, Dhia Eldin Elhag and Abutalib Alamin

ABSTRACT

Objective: To assess the stability of Bisoprolol Fumarate under different stress conditions. Methods: Different samples of Bisoprolol Fumarate standard were subjected to a variety of stress conditions as a temperature, a combination of temperature and relative humidity, direct sunlight, acid/base hydrolysis, and oxidation were subsequently analysed. The analysis was carried out using RPHPLC system equipped with UV/vis detector. Results: Bisoprolol Fumarate was stable in diluent when exposed for 72 hrs (at room temperature). The results of analysis showed that the drug standard was 99.50% which proves that no degradation. When the drug was subjected to 75ºC for 6 hours (Dry Temperature), there was no change in drug potency. No change in the assay content when Bisoprolol Fumarate was exposed to a temperature of 105ºC for one hour. Upon exposure to sunlight in a temperature recorded between (35-40ºC) for 72 hours, Bisoprolol Fumarate was unstable, the drug content decreased to 95.73%. The effect of heat and relative humidity was a decreased in drug assay (i.e. from 99.69% to 93.78%) for one month. Bisoprolol Fumarate was affected by acid and base hydrolysis (0.1M), the drug content was decreased from 99.96% to 94.72% and 91.60% respectively. Moreover, the drug was affected by oxidation (30% H2O2) and the drug content decreased from 99. 96 % to 96.91%. Conclusion: Bisoprolol Fumarate stability was effected when exposed to different stress conditions.

Keywords: Stability, Bisoprolol Fumarate, Stress conditions.