HPLC-MS Method for the Analysis of Tirzepatide in Pharmaceutical Formulation Mounjaro on Solid-Core Primesep SB Column

https://sielc.com/hplc-ms-method-for-analysis-tirzepatide-primesep-sb
⬇ PDF Download

Chromatogram

Description

· High Performance Liquid Chromatography (HPLC) Method for Analysis of Tirzepatide

Tirzepatide is a synthetic peptide that functions as a dual agonist of the GLP-1 and GIP receptors. It is used in the treatment of type 2 diabetes and obesity. By mimicking the actions of both glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP), tirzepatide enhances insulin secretion, reduces blood sugar levels, promotes satiety, and aids in weight loss.

Tirzepatide can be retained and analyzed using the Solid-Core Primesep SB stationary phase column. The analysis utilizes a gradient method with a simple mobile phase consisting of water, acetonitrile (MeCN), and Ammonium formate. Detection was performed using UV absorption at 280 nm. Mass spectrometric detection was carried out in ESI-SIM mode, monitoring the ions [M+3H]³⁺ at m/z 1606

Method Parameters

Mobile PhaseGradient MeCN 40-80%, 10 min
BufferAmmonium Formate pH 3.0 – 40 mM
Flow Rate0.5 ml/min
DetectionUV 280 nm, ESI-SIM: [M+3H]3⁺ -1606
LOD8 ppb
Class of CompoundsGLP-1 Receptor Agonist
Analyzing CompoundsTirzepatide

HPLC Column Used

Solid-Core Primesep S, 3.2 x 100 mm, 2.7 µm, 90 A, dual ended