A novel technique for trehalose and sucrose determination in therapeutic monoclonal antibodies using a high-performance liquid chromatography–evaporative light scattering detector

Abstract

Sucrose and trehalose are commonly used excipients in therapeutic monoclonal antibodies that play a pivotal role in ensuring the safety and stability of drugs. Though it is necessary to control the concentrations of these substances during the quality control of their release, there is currently no comprehensive method for simultaneously determining sucrose and trehalose concentrations. Herein, we established a high-performance liquid chromatography–evaporative light scattering detector (HPLC-ELSD) method and validated it in accordance with the International Council for Harmonization Q2 guidelines. This method utilized the Poroshell 120 HILIC-Z chromatographic column and effectively separated sucrose and trehalose with a detection limit of 0.001 mg/mL. The accuracy recovery rate was within a range of 90%–110 %, and the precision relative standard deviations were all less than 5.0 % (n = 6). The method thus demonstrated good repeatability and linearity, making it suitable for determining the sucrose and trehalose concentrations in therapeutic monoclonal antibodies.

Keywords

• Therapeutic monoclonal antibodies
• High-performance liquid chromatography
• Evaporative light scattering detector
• Trehalose
• Sucrose