Identification of Impurities and Degradation Products in Pharmaceutical Products-Role of Hyphenated Techniques

Abstract

Impurity profiling and identification of degradation product is an essential part of pharmaceutical development program. Impurity profiling is mandatory requirement by various regulatory agencies and is directly related with the quality, safety and efficacy of a drug product. The ultimate purpose of impurity profiling and stress testing is in the establishment of the degradation products pathways and to investigate the stability-indicating power of the analytical procedures which is ultimately helpful in the prediction of shelf life of drug product. Hyphenated technique is combination a combination of two different analytical techniques with the help of proper interface. Mainly chromatographic techniques are combined with the spectroscopic techniques. This write up provides a review on brief information about role of different hyphenated analytical techniques such as HPLC-UV, HPLC-MS, GC-MS and UPLC-MS/MS for identification of impurities and degradation products in pharmaceutical products.