1Assistant Professor, Department of Pharmaceutical Quality Assurance, Shree Dhanvantary Pharmacy College, Kim, Surat-394110, Gujarat, India
2Professor and HOD, Department of Pharmaceutical Quality Assurance, Shree Dhanvantary Pharmacy College, Nr. Railway Station, Kudsad Road, Kim (E), Surat-394110, Gujarat, India
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.
Anti-Diabetic Drugs, Impurity, Spectroscopic Methods, Chromatographic methods, Characterization
