Analysis method for determination of mixed monosaccharides and oligosaccharides in iron isomaltoside by HPLC-ELSD

The method of separating and detecting monosaccharides and oligosaccharides in isomaltose iron by HPLC-ELSD solves the problem of separation difficulties in existing technologies, realizes a highly efficient and sensitive detection method, and ensures the quality of drug products.

CN122361680APending Publication Date: 2026-07-10CENT SOUTH UNIV
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Patent Information

Application Number
CN202610822269.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-06-09
Publication Date
2026-07-10

AI Technical Summary

Technical Problem

Existing technologies are insufficient for effectively separating and detecting the content of monosaccharides and oligosaccharides in isomaltose iron 1000, making it difficult to control the quality of the active pharmaceutical ingredient.

Method used

The mixed monosaccharides and oligosaccharides in isomaltose iron were separated and detected by HPLC-ELSD using a high-performance liquid chromatography-evaporative light scattering detector with specific gradient elution conditions and an amide-bonded silica column.

Benefits of technology

It achieves effective separation and detection of monosaccharides and oligosaccharides in isomaltose iron anhydride, ensuring product quality. It features excellent chromatographic peak shape, high sensitivity, and simple operation, and can control the content of monosaccharides and oligosaccharides in drugs.

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Abstract

This application relates to the field of testing and analysis technology, and in particular to an analytical method for determining mixed monosaccharides and oligosaccharides in isomaltose iron using HPLC-ELSD. This application employs high-performance liquid chromatography-evaporative light scattering detector (HPLC-ELSD) to detect isomaltose iron solutions; wherein the HPLC conditions include gradient elution with water as mobile phase A and acetonitrile as mobile phase B under specific elution conditions. This method allows monosaccharides and various oligosaccharides to elute sequentially, with good separation between peaks, good peak shapes, simple operation, high sensitivity, good robustness, and good control over product quality.
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Citation Information

Patent Citations

  • Method for detecting carbohydrate content in ferric carboxymaltose

    CN111077252A

  • Method for identifying polyferose

    CN116429928A