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Updated: Jul 25, 2026

Sampling Human Indigenous Saliva Peptidome Using a Lollipop-Like Ultrafiltration Probe: Simplify and Enhance Peptide Detection for Clinical Mass Spectrometry

Sampling Human Indigenous Saliva Peptidome Using a Lollipop-Like Ultrafiltration Probe: Simplify and Enhance Peptide Detection for Clinical Mass Spectrometry

Published on: August 7, 2012

Identificación y cuantificación de impurezas peptídicas estructuralmente relacionadas en linaclotida mediante

Jinlan Cheng^1,2, Tianji Zhang², Xinling Cui²

¹School of Pharmacy, China Medical University, Shenyang, China.

Rapid communications in mass spectrometry : RCM

|January 15, 2026

Abstracto

Rationale:

Linaclotide is an important peptide drug used to treat irritable bowel syndrome with constipation (IBS-C). However, structurally related impurities in peptide drugs can be generated during synthesis, storage, or transport, which compromise the quality and safety. Therefore, developing a highly sensitive analytical method for impurity detection is of great significance.

Methods:

A liquid chromatography-high resolution mass spectrometry (LC-HRMS) method was developed. Linaclotide samples were directly analyzed using an Orbitrap mass spectrometer with an electrospray ionization (ESI) source operated in positive ion mode. Tandem mass spectrometry with collision-induced dissociation was utilized. The method leveraged high mass accuracy to identify and quantify structurally related peptide impurities in linaclotide samples from different manufacturers.

Results:

The method was applied to characterize the peptide impurities in linaclotide study materials. In manufacturer A's material, [Des-Tyr¹⁴]-linaclotide was found at 0.453 mg/g. The same impurity was found in manufacturer B's material at 0.768 mg/g, as well as another impurity [endo-Ala⁹]-linaclotide at 0.555 mg/g.

Conclusions:

The developed LC-HRMS method successfully addresses the challenge of determining structurally related peptide impurities in linaclotide. Its ability to characterize specific impurities provides a valuable complement to existing quality control strategies for peptide therapeutics.

Palabras clave:

espectrometría de masas de alta resolución impureza linaclotida cromatografía líquida

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