PROFILING OF IMPURITIES IN PHARMACEUTICAL FORMULATIONS

Impurity profiling is the process of evaluating data for the biological safety of an individual impurity. Impurity profiling has gained utmost importance due to the fact that unidentified impurities present in the pharmaceutical formulations may prove hazardous to human health on consumption. Impurities in pharmaceuticals are unwanted compounds that remain or those that are present during the formulation of drugs. A number of regulatory agencies like USFDA, ICH and Canadian Drug and Health Agency are emphasizing on the purity requirements as well as identification of impurities in active pharmaceutical ingredients. Impurity profiling, helps in the detection, identification, and quantification of various types of impurities present in pharmaceutical formulations. Identification of impurities can be done by using either chromatographic or spectroscopic techniques alone or by combination of both. A number of methods have been used for detecting and characterizing impurities using HPLC, HPTLC, AAS, TLC, etc. However the most exploited techniques used today for impurity profiling of drugs include LC-MS, GC-MS, NMR-MS, LC-MS-MS and LC-NMR. Therefore, this review focuses on the importance of impurity profiling and the need for identification, quantification and qualification of impurities present in pharmaceuticals