Stability Study of Glibenclamide and Validation of its UV. Spectrophotometric Quantification Method

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.