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Published on: September 25, 2017
Regulatory Updates and Analytical Methodologies for Nitrosamine Impurities Detection in Sartans, Ranitidine,
Khaja Moinuddin Shaik1, Bhaskar Sarmah1, Gaurav Suresh Wadekar1
1Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER-Guwahati), Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Govt. of India, Guwahati, Sila Katamur (Halugurisuk), P.O.: Changsari, Dist: Kamrup, Assam, India-781101.
Abstract:
Nitrosamine impurities have been detected in various pharmaceutical products in recent days. Various sartans, ranitidine, nizatidine, and metformin have been recalled from the markets due to the high limit of nitrosamine impurities. This review aims to provide a brief overview of nitrosamine impurities, detection methods in detail, mechanism of action of nitrosamine impurities, sample preparation techniques, and regulatory limits. Numerous reported nitrosamine impurities also have been discussed with chemical structure. Various detection methods including LC-MS/MS, GC-MS-HS, and HPLC for nitrosamine impurities along with sartans, ranitidine, nizatidine, and metformin are being discussed in this review article. Various sample preparation techniques such as solid-phase extraction, liquid-liquid extraction, and rapid-fire techniques have also been discussed. This review will provide the detail information to the analytical manpower working in various quality control laboratories as well as in research organizations. HighlightsDetection of nitrosamine (NA) impurities in drug substances as well as finished products.HPLC, LC-MS/MS, and GC-MS/HS/AS discussed for the quantificationSolid-phase extraction, liquid-liquid extraction, and rapid-fire method for NA sample preparationMechanistic approach for nitrosamine formation and its removal strategiesRegulatory limits for NA impurities incorporated.
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