Abstract
IN-VITRO COMPARATIVE STUDY OF METFORMIN/GLYBURIDE COMBINATION GENERIC BRAND TO THE ORIGINATOR
Abdrhman M. Gamil*, Ali Elmardi M. Hussein and baa K. Ibrahim
ABSTRACT
The Sudan Pharmaceutical industry was slowly growing. Many generic brands are produced, the quality of which should be verified. To achieve this verification and guarantee the quality, glyburide/Metformin combination brand, GA, was tested for similarity with the originator; Glucovance and testing its uniformity in content. The physical properties were found to be within the specified limits. The API contents in both product s were within the pharmacopoeial limits. On studying the dissolution profile the similarity factor f2 is 75 for the glyburide component and 80 for metformin component while the difference factor f1 is 11 for glyburide component and 7 for the metformin components, indicating close similarity. The uniformity of content was within the USP limits. It had been concluded that Sudan pharmaceutical industry is promising and can produce acceptable quality to satisfy the population needs.
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