Insight into Analytical Techniques for the Detection of Nitrosamine Impurities: A Review

Abstract

Nitrosamine impurities in pharmaceutical products have increased attention for safety in the direction of the use of various drugs. Nitrosamines are the class of compounds which represents nitroso group attached to an amine (R1N(-R2)-N=0). Nitrosamines are molecules that have a nitroso group connected to an amine (R1N(-R2)-N=0). Controlling cancer-causing contaminants in pharmaceutical products is critical for predicting and avoiding the carcinogenic risk of medicine in people. According to recent findings, nitrosamine impurities have increased the medicinal product's carcinogenic risk. The literature search was accomplished using PubMed, Google scholar, and the Cochrane library to identify relevant scientific articles using various sensitive techniques and analytical instruments for the detection of nitrosamine impurities from the years 1981 to 2022. The search terms included nitrosamine detection techniques, formation of nitrosamine, HPLC technique for nitrosamine detection, GC-MS/MS, GC-MS/MS, GC-MS-Head space, and GC-QTOF technique for nitrosamine detection, LC-MS/MS technique for nitrosamine detection, The literature search included 29 scientific articles from the English lamnguage, including original research and standard guidelines intended to review all the sensitive techniques for detection of nitrosamine impurities in pharmaceutical products. The current review aims to discuss the highly sensitive, cost effective, accurate and precise methods for the detection of various nitrosamine contaminations in the pharmaceutical products.