Abstract

RECENT TRENDS IN IMPURITY PROFILING METHODS USING ANALYTICAL TECHNIQUES

M.D. Phatangare, M.M. Deshpande*, P.S. Sanap, R.N. Kachave and M.J. Chavan

Abstract

Any component of the new drug substance that is not the chemical entity defined as the new drug substance or excipient in the drug product. Now a days, Impurity profile has become mandatory according to various regulatory authorities. This review describes the recent trends in analytical perspectives of Impurity Profiling. In this review article mainly focuses an various method available to identify & characterize impurities in pharmaceutical dosage form. The highlights the different types of impurities & various method for isolation, separation & characterization of impurities. There are different methods for detecting & characterization impurities with TLC,HPLC,HPTLC,AAS. etc.

Keywords: Impurity profiling, Isolation, Identification.