Immunomodulator Pitodimod: Degradation and Impurity Profile Study

Abstract

Pidotimod is an immunostimulant, used to treat recurrent and acute respiratory tract infections. Degradation and impurity profiling is one of the most fascinating, and important areas of pharmaceutical analysis because current regulations and standards demand that the pharmaceutical industry should develop highly pure drug substances alongwith an in depth understanding of the degradants and impurities. This book chapter covers the identification, quantification and structural characterization of process and degradation related impurities of Pidotimod in bulk drugs and their formulations. Pidotimod stress testing and degradation profiling were carried out under ICH-recommended stress degradation protocols. The impurities and degradats were separated on RP-C-18 column and based on LC-MS-MS study the structures of degradants were postulated. The isolated impurity was characterized based on IR, Mass and NMR analysis.