A method for the isolation and detection of components in a preparation of ademetionine butanedisulfate

By using a high-performance liquid chromatography method with a specific mobile phase and gradient elution procedure, the problems of inaccurate adenosine detection and column damage in the prior art have been solved, and efficient separation and accurate detection of adenosine in S-adenosylmethionine disulfate preparations have been achieved.

CN120594719BActive Publication Date: 2025-11-25HANGZHOU HUANGSEN BIOLOGICAL TECH CO LTD
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Patent Information

Application Number
CN202511107415.3
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-08-08
Publication Date
2025-11-25
Estimated Expiration
2045-08-08

AI Technical Summary

Technical Problem

There is a lack of effective detection methods in the current technology to control the adenosine content in S-adenosylmethionine disulfate preparations, and existing methods may damage the chromatographic column and are not suitable for gradient elution.

Method used

Ammonium formate solution-water-acetonitrile and ammonium formate solution-acetonitrile-methyl tert-butyl ether were used as mobile phase systems. A gradient elution program was used to separate S-adenosylmethionine and related impurities by high performance liquid chromatography, and the impurities were detected by ultraviolet detector or mass spectrometry.

Benefits of technology

It achieves efficient separation and accurate detection of S-adenosylmethionine and related impurities, with high separation efficiency, low cost, accurate detection results that are not affected by excipients, and is suitable for gradient elution while protecting the chromatographic column.

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Abstract

The application provides a method for separating and detecting ingredients in a butanedisulfonic acid ademetionine enteric-coated tablet, and belongs to the technical field of drug quality analysis. The application uses ammonium formate solution-water-acetonitrile and ammonium formate solution-acetonitrile-methyl tert-butyl ether as a mobile phase system, and controls the pH value of the ammonium formate solution to be 2.2-3.1, so that adenosine and adenine can be effectively separated, and ademetionine, decarboxylated ademetionine, S-adenosyl-L-methionine glycine isomer 2, adenosine, adenine and S-adenosyl-L-homocysteine can be highly separated at one time, the method has the advantages of short time consumption, high separation efficiency, simple operation, low separation cost, and is favorable for improving the quality control of butanedisulfonic acid ademetionine or related preparations. In the application, the detection of ademetionine and related impurities is not affected by excipients, and has the advantages of high efficiency, convenience, good reproducibility, strong specificity, high accuracy and high sensitivity, and can realize the quality control of ademetionine samples.
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