Method for detecting content of D-choline alfoscerate in L-alpha-choline alfoscerate and application

By combining HPLC-ELSD with a chiral normal-phase column and an evaporative light scattering detector, the problem of detecting D-glucosine isomer impurities in high-purity L-α-glucosine was solved, achieving rapid and accurate quantitative analysis, reducing detection costs and extending column life.

CN122259775APending Publication Date: 2026-06-23JYOUKI PHARM CO LTD +1
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Patent Information

Application Number
CN202610710306.9
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-05-22
Publication Date
2026-06-23

AI Technical Summary

Technical Problem

Existing technologies cannot effectively and accurately detect and quantify low levels of D-glucosine isomer impurities in high-purity L-α-glucosine, leading to difficulties in purification and refining processes, as well as high detection costs and long processing times.

Method used

The HPLC-ELSD method was used with a cellulose-type chiral normal-phase column covalently bonded to polysaccharides on silica gel or coated with polysaccharides on silica gel, combined with an evaporative light scattering detector. The efficient separation and quantification of D-phosphoric acid choline in L-α-phosphoric acid choline was achieved through isocratic elution and appropriate mobile phase combination.

Benefits of technology

This method enables rapid and accurate detection of D-glucosamine isomer impurities in L-α-glucosamine choline, reducing detection costs, improving detection sensitivity and reproducibility, and extending the lifespan of chiral chromatographic columns.

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Abstract

The invention belongs to the technical field of chemical analysis, and particularly relates to a method for detecting the content of D-choline alfoscerate in L-alpha-choline alfoscerate and application. According to the detection method, a silica gel surface polysaccharide covalently bonded cellulose type or silica gel surface polysaccharide coated cellulose type normal phase chromatographic column and an evaporative light scattering detector (ELSD) are selected, detection is carried out through an HPLC-ELSD method, and the method has the advantages of being easy and convenient to operate, high in sensitivity and good in method specificity and reproducibility; the method is a high performance liquid chromatography method convenient for standardized operation, and can completely separate L-alpha-choline alfoscerate from low-limit D-choline alfoscerate isomer impurities and accurately quantify the impurities.
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