Pharmaceutical Evaluation of Type II Oral Antidiabetic Agent
In this study, the pharmaceutical evaluation including physical and chemical evaluation of commercial Glibenclamide tablets (Gliboral®, Glynase® and Glib-5®) that are available in the Libyan market was performed according to the British Pharmacopoeia (BP) monograph (2009). The obtained results from this work indicated that, significant differences in the dissolution behavior were observed between the different tested commercial products. Gliboral® exhibited the lowest dissolution profile while the other products showed dissolution profiles that were almost twice that of Gliboral®. However, no significant differences were observed for the percentage (%) of weight loss (friability) and disintegration time for the tested products with % RSD value of less than 2 %. Additionally, all products were found satisfactory in terms of identification using infrared (IR) spectroscopy in comparison to reference spectra. Moreover, the assay results for the % content of glibenclamide using high performance liquid chromatography (HPLC) showed that all tested products were found to pass and satisfied with the BP specifications which required glibenclamide content to be within the range of 95 to 105 % of the labeled content. The precision of the analysis was also evaluated and calculated and the results showed good precision (interday and intraday) with % RSD value of less than 1.9 % (based on 6 injections).