Abstract:
In this thesis, the drug Glibenclamide, which is known by several commercial names, such as, Daonil, Euglucon, and Delmide, had been submitted to a stability study in terms of its stability as a raw material, by following stability study protocols, including heat factors, humidity, periods of storage, and transportation. The obtained results were compatible with specifications required by the British Pharmacopoeia.
A UV spectrophotometric method to determine the drug according to the accepted worldwide verification standard was developed and validated. The method has been characterized as simple way, rapid , low cost and accurate.
The method had been tested by analyzing the final product samples from different companies, by a number of analyst’s chemists, using different UV spectrophotometers. The obtained results were satisfactory and consistent with the required pharmaceutical specifications, the relative standard deviation was less than 2%, which confirmed the accuracy of the performed method, and its suitability to conduct routine tests of pharmaceutical doses, and large quantities.