Research Projects

Origin of proposal: Nitrosamines are the carcinogenic impurities found in several pharmaceutical products, which possess serious threat to human health. A large number of drug products have been recalled from the market due to detection of nitroimine impurity. NDMA is one of the most common nitrosamine impurity which was found above acceptable limit in drug products including angiotensin-II receptor blockers, antidiabetic drugs, histamine-2- receptor antagonists, etc. The available analytical methods (e.g., LC-MS, GC-MS, etc.) for the detection of NDMA impurity for the quality control of drug products are complex, time consuming and require sophisticated instruments. Thus, a simple, rapid, and cost-effective method for the detection of NDMA impurity is need of the hour to maintain the quality of drug products. Novelty: Novelty of the proposed work lies in the development of a rapid and cost-effective detection technique of NDMA impurity using aptamer based electrosensor. The electrosensor will be able to detect NDMA impurity rapidly, excluding requirement of complex process and technical expertise. Objective: The objective of the proposed work is to develop a suitable aptamer based electrosensor for the rapid detection of NDMA impurity in active pharmaceutical ingredients (APIs) and drug products. Methods: Here we are proposing development of aptamer based electrosensor where the aptamer will be screened through capture SELEX technique. The capture SELEX comprises of target induced selection, enrichment, and isolation of DNA aptamers. The electrosensor will be developed with reservoirs of (solvent + aptamer) solution and (solvent + aptamer + NDMA) solution. The shift in the base current among the reservoirs will be used for the sensing purpose. Expected outcome: The expected outcome of the proposed work is the development of aptamer based electrosensor for the detection of NDMA impurity in the APIs and pharmaceutical drug products.