Abstract

IDENTIFICATION OF DEGRADANTS OF THERMAL STRESS STUDIES OF DAPAGLIFLOZIN TABLETS BY HPLC-PDA AND LC-MS INSTRUMENTAL TECHNIQUES

Ashok Reddy Bheemi Reddy, Trivikram Naidu Uppuluri, Rakesh Bhooshanavoyina,
Dr. Akuthota Ashok Kumar*, Dr. Rajesh Vooturi

ABSTRACT

Objective of the manuscript is to identify the degradants observed in the thermal degradation sample of Dapagliflozin tablets by using LC-MS and HPLC-PDA techniques. Thermal degradation sample was injected in HPLC-PDA and LC-MS instruments. Mass of the degradants were detected by LC-MS technique, which were assigned to the probable structures correlating with the impurities mentioned in the USP monographs of Dapagliflozin tablets. The assigned probable structures for the degradants were confirmed by procuring and confirming by injecting in HPLC-PDA detector and LC-MS instruments.

Keywords: Dapagliflozin, Impurities, Degradants, Structures, HPLC-PDA, LC-MS.