Date of Award

8-2022

Access Control

Open Access

Degree Name

Forensic Science, M.S.

Department

Chemistry Department

Advisor

Joonyeong Kim, Ph.D.

First Reader

Joonyeong Kim, Ph.D.

Second Reader

Jinseok Heo, Ph.D.

Third Reader

Sujit Suwal, Ph.D.

Abstract

Irinotecan is a cancer medication approved for medical use in the United States in 1996. It is currently administered via intravenous injection. However, intravenous dosing has disadvantages such as requirement of administration by a trained professional in a medical facility, possible severe adverse effects, pain at the injection site, and possible hemolysis if injected too rapidly. Previously oral administration was not feasible because the p-glycoprotein (p-GP) on the cell membrane of stomach cells acts as a defense mechanism against harmful substances by pumping the irinotecan back into the intestinal lumen for excretion. With the discovery of the p-GP inhibitor encequidar by Athenex Pharmaceuticals, the combination of oral encequidar and irinotecan allowed for the convenience of oral administration of irinotecan. This project reports the detection, structural identification, and control of unspecified impurities in the oral irinotecan product. Analytical techniques used to quantitate and monitor the impurities in the oral irinotecan include high performance liquid chromatography (HPLC) and ultra-performance liquid chromatography (UPLC) equipped with ultraviolet visible light detector (UV-Vis) and tandem mass spectrometry (LC-MS/MS). Basic principles and method development via these analytical techniques and other quality control techniques will be discussed.

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