Method for detecting oxcarbazepine and related substances in oxcarbazepine oral solution and quality control method

CN122109347APending Publication Date: 2026-05-29WUHAN WUYAO SCI & TECH CO LTD

Patent Information

Authority / Receiving Office
CN Β· China
Patent Type
Applications(China)
Current Assignee / Owner
WUHAN WUYAO SCI & TECH CO LTD
Filing Date
2024-11-20
Publication Date
2026-05-29

AI Technical Summary

Technical Problem

Existing methods for detecting aminocaproic acid oral solution powder have problems such as poor impurity separation, insufficient specificity, low sensitivity, poor reproducibility, and high cost, making it difficult to meet the detection needs of the industry.

Method used

High performance liquid chromatography (HPLC) was used with phosphate solution and acetonitrile as the mobile phase. The concentration of phosphate solution was controlled between 0.1 mM and 10 mM. Gradient elution and a hydrophilic column were combined to separate and detect aminocapric acid and related substances.

Benefits of technology

It achieves high specificity, accuracy, sensitivity and stability for aminohexenoic acid and related substances, is easy to operate, and is suitable for a wide range of applications. The chromatographic peak resolution between the main peak and adjacent substances is not less than 1.5.

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Abstract

The present application provides a detection method and quality control method for related substances in dextromethorphan oral solution, which comprises the following steps: dissolving dextromethorphan oral solution in a solvent to obtain a test solution; and performing high performance liquid chromatography detection on the test solution; the mobile phase used in the high performance liquid chromatography detection comprises mobile phase A and mobile phase B, the mobile phase A comprises a phosphate solution, the mobile phase B comprises acetonitrile, and the concentration of the phosphate solution is 0.1 mM-10 mM. The detection method has good linear relationship between dextromethorphan and related substances, good accuracy and sensitivity, strong specificity, high stability, good separation degree and good reproducibility, and is suitable for wide application.
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