Dhara Vashi, Suresh Kumar
Dhara Vashi1, Suresh Kumar2*
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.
Volume - 9,
Issue - 4,
Year - 2019
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 like HPLC(High performance liquid chromatography), TLC(Thin layer Chromatography), HPTLC(High Performance thin layer chromatography), GC(Gas chromatography) used for identification, isolation and characterization of Impurities present in pharmaceuticals. Various hyphenated techniques are used for 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.
Cite this article:
Dhara Vashi, Suresh Kumar. Impurity Identification and Characterization of some Anti-Diabetic Drugs using various Analytical Methods. Asian J. Pharm. Res. 2019; 9(4):243-248. doi: 10.5958/2231-5691.2019.00039.X