Determination method of 4-hydroxy-7-phenoxyisoquinoline-3-carboxylic acid methyl ester and its related substances

Through reverse phase liquid chromatography and gradient elution technology, the separation and detection problems in the determination of methyl 4-hydroxy-7-phenoxyisoquinoline-3-formate and its related impurities were successfully solved, achieving efficient and accurate analysis results, and improving the quality and safety of raw materials.

CN115656356BActive Publication Date: 2025-03-21ZENJI RES LAB
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Patent Information

Application Number
CN202211207188.8
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2022-09-30
Publication Date
2025-03-21
Estimated Expiration
2042-09-30

AI Technical Summary

Technical Problem

There is a lack of effective determination methods in the prior art to isolate and detect methyl 4-hydroxy-7-phenoxyisoquinoline-3-carboxylate and its related impurities, which affects the quality and safety of the raw materials.

Method used

Reverse phase liquid chromatography was used, and the gradient elution technology was used to use aqueous trifluoroacetic acid solution and acetonitrile as mobile phase, combined with an ultraviolet absorption detector and an octadecylsilane-bonded silica gel chromatography column to achieve effective separation and detection of 4-hydroxy-7-phenoxyisoquinoline-3-formate and its impurities.

Benefits of technology

This method is stable, effective and simple to operate, and can efficiently separate target substances and impurities. It has strong retention ability of sample components, good separation degree, accurate detection results, high sensitivity, good specificity, repeatability and linearity.

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Abstract

The invention discloses a method for determining 4-hydroxy-7-phenoxyisoquinoline-3-methyl formate and related substances, and belongs to the technical field of drug analysis. The method adopts reverse phase liquid chromatography to detect and analyze 4-hydroxy-7-phenoxyisoquinoline-3-methyl formate and related substances impurities A, impurity B, impurity C, impurity D, and impurity E, and uses octadecylsilane bonded silica gel as a chromatographic column as a filler, mobile phase A is trifluoroacetic acid aqueous solution, mobile phase B is acetonitrile, and gradient elution is adopted. The method has the advantages of high sensitivity, accurate impurity content determination results, good specificity, repeatability and linearity.
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