Quantitative Determination of Semaglutide and Preservative in Semaglutide Injection by High Performance Liquid Chromatography

User Benefits

- This method enables simultaneous quantification of both the active ingredient and the preservative in semaglutide injection using a single sample injection. - The method demonstrates excellent repeatability and is simple to operate.

Introduction

Semaglutide is a long-acting glucagon-like peptide-1 (GLP-1) analog that exerts its effects by activating insulin receptors, promoting insulin secretion, and suppressing glucagon secretion. It is primarily used in the treatment of type 2 diabetes and has also shown potential in weight management. In multi-dose formulations of semaglutide injection, a certain concentration of phenol is added as a preservative to inhibit microbial growth. The Chinese Pharmacopoeia sets specific requirements for preservative content in pharmaceutical preparations, with phenol typically maintained at around 0.5 %. Currently, there is limited published literature on analytical methods for semaglutide formulations. Therefore, developing a validated analytical method for quality control of semaglutide injection is of significant practical value in ensuring product quality and enhancing medication safety and consistency for patients. This article establishes a high-performance liquid chromatographic (HPLC) method for the determination of semaglutide and the preservative phenol in semaglutide injection. The method has been fully validated and is provided here as a reference for relevant professionals.

September 8, 2025 GMT