Abstract
Various regulatory authorities such as the International Conference on Harmonization (ICH), The United States Food and Drug administration (FDA) are emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredients (APIs). Now a day research give great exposure to impurity profiling and forced degradation study of Active pharmaceutical ingredient and combined dosage form used for the treatment of Diabetic. Anti-Diabetic drugs class include: Sulfonylureas, Meglitinides, Thiazolidinediones, Alpha-glucosidases inhibitor, Dipeptidyl-peptidase-4 (DPP-4) inhibitors, Glucagon-like peptide-1 (GLP-1) agonist, Sodium glucose co-transporter 2 (SGLT2) inhibitors. As per ICH, Impurity profiling description of the identified and unidentified impurities present in a typical batch of API produced by a specific controlled production process. There are number of Spectroscopic method like UV(Ultraviolet Spectrometry), MS(Mass spectrometry), IR (infrared spectroscopy), NMR(Nuclear magnetic resonance) and Chromatographic methods identification and better resolution between impurities having near to similar structure with each other or with APIs like Liquid Chromatography (LC)-Mass Spectroscopy (MS), LC-NMR, LC-NMR-MS, GC-MS, and LC-MS. This leads interest of impurity profiling in pharmaceuticals.
Published Version
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