Method for detecting related substances of 5 '(E)-VPA phosphoramidite monomer

By optimizing the detection conditions using liquid chromatography, the gap in the detection of related substances of 5'(E)-VPA phosphoridamide monomer was filled, enabling quality control of small nucleic acid drugs and improving detection efficiency and accuracy.

CN121027346APending Publication Date: 2025-11-28QINGDAO TANGZHI PHARM TECH CO LTD
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Patent Information

Application Number
CN202511069596.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-07-31
Publication Date
2025-11-28

AI Technical Summary

Technical Problem

The lack of effective methods in the current technology for detecting relevant substances in 5'(E)-VPA phosphorous amide monomers increases the difficulty of purifying small nucleic acid drugs and affects drug quality control.

Method used

The detection was performed using liquid chromatography with an octadecyl-bonded silica column, ammonium acetate solution and acetonitrile as the mobile phase, gradient elution, and a UV detector. The detection conditions were optimized to avoid sample degradation, thus achieving accurate separation and detection of related substances of 5'(E)-VPA phosphorous amide monomer.

Benefits of technology

It achieves effective separation and detection of related substances of 5'(E)-VPA phosphorous amide monomer, meets pharmacopoeia standards, reduces analysis costs, can complete the detection of multiple impurities in a short time, truly reflects sample quality, and is suitable for quality control of small nucleic acid drugs.

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Abstract

The invention discloses a method for detecting 5 '(E)-VPA phosphoramidite monomer related substances, and belongs to the technical field of liquid chromatography detection. Related substances comprise 5 '-(E)-VP-2'-OMe-A (Bz), 5 '(Z)-VPA, 5'-(E)-VP-2 '-OMe-A-CE-P and 5' (E)-VPA-OX, and chromatographic detection conditions comprise that the column temperature is 23-27 DEG C, a stationary phase of a chromatographic column is octadecyl bonded silica gel, a mobile phase A is an ammonium acetate solution, a mobile phase B is acetonitrile, gradient elution is performed, and the like. According to the method, four related substances in the 5 '(E)-VPA phosphoramidite monomer are effectively separated through specific liquid chromatography conditions, the system adaptability, specificity, linearity and range, detection limit, quantitation limit and accuracy verification of the method all meet acceptable standards of pharmacopoeia, and detection of multiple related substances can be completed within a short time; and a reliable means is provided for detecting and controlling the quality of the 5 '(E)-VPA phosphoramidite monomer.
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