Abstract

The pharmaceutical quality of five generics of glibenclamide that are available in the Jordanian market was assessed according to the British Pharmacopoeia (BP) monograph (2009). Similarly, the originator glibenclamide (Daonil^®) which was obtained from the Saudi market was subjected to analysis and used as a reference product. All products were found satisfactory in terms of identification and related substances as per the BP requirements. However, the assay results showed that only two products, in addition to the reference (Daonil^®) satisfied the BP specifications which required glibenclamide content to be within the range: 95 to 105% of the labeled content. All products, in spite of marginal deviations for two of them, were found to pass the United States Pharmacopoeia (USP) assay specifications (90 to 110%). Significant differences in dissolution behavior were observed between the different generics and the originator (Daonil^®). Daonil^® exhibited the lowest dissolution profile while some products showed dissolution profiles that were almost twice that of Daonil^®.

Key words: Glibenclamide tablets, pharmaceutical equivalency, dissolution testing, quality control.