Thesis (M.Sc.) - Cairo University - Faculty of Pharmacy - Department of Analytical Chemistry

This thesis deals with using different analytical techniques for analysis of some carbonyl group containing drugs, namely 2paracetamol with its co-formulated drugs phenylephrine hydrochloride and doxylamine succinate{u2019}{u2019}and 2ibuprofen with its co-formulated drug diphenhydramine citrate3. Identification and quantification of impurities is required by different regulatory authorities as it is a crucial task in pharmaceutical process development for quality and safety. Some impurities were developed during the formulation process and others may be upon aging of either active ingredients or the formulation.There are three types of impurities ;organic impurities which arise during synthesis process or storage of drug substances , inorganic impurities which arise from the manufacturing process and residual impurities which arise during various steps of synthesis and purification. Moreover, the presence of these unwanted compounds even in small amounts may influence the efficacy and safety of the pharmaceutical products.Therefore, ICH guidelines require identification and quantification of impurities to improve the quality of drugs and the safety and efficacy of drug therapy.The aim of this work was to develop analytical methods capable of selective determination of the intact drugs in presence of their impurities

Issued also as CD