The present study deals with the forced degradation behavior of dexlansoprazole under International Conference on Harmonisation(ICH)prescribed stress conditions. The drug was found to be more labile under acid,base,ne...The present study deals with the forced degradation behavior of dexlansoprazole under International Conference on Harmonisation(ICH)prescribed stress conditions. The drug was found to be more labile under acid,base,neutral,oxidative hydrolysis and thermal stress,while it was moderately stable under photolytic conditions. The known and unknown degradation products were separated on a C-18 column using a stabilityindicating method. Liquid chromatography-mass spectrometry(LC-MS)analysis was performed for all the degradation studies. Isolation and structure characterization of oxidation degradation products were executed using sophisticated tools,viz. preparative high performance liquid chromatography(HPLC),liquid chromatographymass spectrometry / time of flight(LC-MS / TOF),liquid chromatography-tandem mass spectrometry(LC-MS /MS),and nuclear magnetic resonance(NMR). This study demonstrates an ample methodology of degradation studies and structure elucidation of unknown degradation products of dexlansoprazole,which helps in the development and stability study of active pharmaceutical ingredients and formulated products.展开更多
基金the management of Dr. Reddy’s Laboratories Ltd. for supporting this work
文摘The present study deals with the forced degradation behavior of dexlansoprazole under International Conference on Harmonisation(ICH)prescribed stress conditions. The drug was found to be more labile under acid,base,neutral,oxidative hydrolysis and thermal stress,while it was moderately stable under photolytic conditions. The known and unknown degradation products were separated on a C-18 column using a stabilityindicating method. Liquid chromatography-mass spectrometry(LC-MS)analysis was performed for all the degradation studies. Isolation and structure characterization of oxidation degradation products were executed using sophisticated tools,viz. preparative high performance liquid chromatography(HPLC),liquid chromatographymass spectrometry / time of flight(LC-MS / TOF),liquid chromatography-tandem mass spectrometry(LC-MS /MS),and nuclear magnetic resonance(NMR). This study demonstrates an ample methodology of degradation studies and structure elucidation of unknown degradation products of dexlansoprazole,which helps in the development and stability study of active pharmaceutical ingredients and formulated products.
