Analytical method development and quantification of Potential and Genotoxic impurities in APIs

Abstract

newline PREFACE newlineImpurity assessment is the description or analysis of utmost number of kinds of newlineidentifiable or strange impurities found inside any API. API-linked impurities, process- newlineallied contaminants, and stability-accompanied impurities are all examples of impurities. newlineChemicals, catalysts, residual solvents, reagents, synthetic intermediate inputs, newlineconcomitants, products after degradation, method conditions associated impurities, and newlineformulation linked impurities are all examples of process-related impurities. Degradation newlineor conversion of APIs, mutual interactions between APIs, and excipients included in newlinemedicinal products are all examples of contaminants that affect stability. The existence of newlinethese undesirable impurities may have an impact on API bioavailability, safety, and newlineefficacy. To guarantee the best medicine quality, the levels of genotoxic impurity should newlineindeed be monitored and controlled using appropriate analytical procedures. newlineSome of the quantitative technologies known for the quantifying impurities in newlinemedicinal compounds are: newlineand#61623; Liquid chromatography - Ultraviolet detection newlineand#61623; Liquid chromatography - Mass spectrometry newlineand#61623; Gas chromatography - Flame ionization newlineand#61623; Gas chromatography - Mass spectrometry newlineand#61623; Inductively tied plasma optical emission spectroscopy newlineand#61623; Capillary electrophoresis newlineand#61623; Supercritical fluid chromatography newlineand#61623; Inductively tied plasma mass spectrometry newlineand#61623; Fourier transform infrared spectroscopy. newlineAndhra University, Visakhapatnam newlineThis is the theme of the present thesis and the following techniques were included in the newlineexisting investigation: newlineand#61623; Head space gas chromatography linked with mass spectrometry. newlineand#61623; High performance liquid chromatography with UV detection newlineand#61623; Head space gas chromatography linked with flame ionization detection. newlineThe Potential and genotoxic impurities of the drug substances determined are the newlinefollowing newlineand#61623; FIP, STG-01, Desfluoro and FHO-2 impurities in Ezetimibe newlineand#61623; Pyrogallol impurity in Trimetazidine dihydrochloride newlineand#61623; Organic volatile