Degradation characterization and method validation of API Molecules by Analytical Techniques

Abstract

newline PREFACE newline newlineThe stability of a drug substance is a critical parameter which may affect potency, newlinesafety and purity. Changes in drug stability can risk patient safety by formation of newlinea toxic degradation product(s), Therefore it is essential to know the purity profile newlineand behaviour of a drug substance under various conditions. newlineIn the present thesis an attempt has been devised to develop rapid , reliable and newlinesimple methodology for control analysis of the selected drugs, available as newlinecombined dosage forms. Literature survey revealed that some analytical methods newlineso far has been reported on these selected drugs in formulations using the applied newlinetechniques and hence, it was considered valuable to undertake this research. newlineThe aim of the proposed research is as under newline- To distinguish impurities related to drug substance or excipients. newline- To isolation and structural conformation of degradation impurities. newline- To define degradation pathways of drug substance and drug products. newline- To identify the drug molecule chemistry. newline- To develop and validate stability indicating method by using UPLC newline- To develop the enantiomeric separation method of drug substance and its newlinedegradation products by using SFC newline- To resolve the stability related challenges (e.g. mass balance) newline1 newlineAndhra University, Visakhapatnam newline newlineThe results obtained are presented in the thesis which is consolidated into five newlinechapters and each chapter is further divided into sections, the references cited newlinein the text are given at the end of the chapters. newline In the first chapter, the author describes the typical introduction of drug, newlineimportance of forced degradation, UPLC method development, method newlinevalidation parameters and isolation, characterisation of degradation products. newlineVarious analytical techniques are involved in characterisation like UPLC, newlineNMR, HRMS, Preparative HPLC and the importance of enantiomeric newlineseparation in super critical fluid chromatography have been presented. newline The second chapter