Separation, identification and content determination method of upatinib intermediate UPA-Z3 and impurities thereof

The separation and detection of utpatinib intermediate UPA-Z3 and its impurities by reverse high performance liquid chromatography solves the separation and detection problems in the existing technology, and realizes the controllability of drug quality and the safety of medication.

CN122449032APending Publication Date: 2026-07-24CHONGQING HUABANGSHENGKAI PHARM CO LTD
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Patent Information

Application Number
CN202510075698.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-01-17
Publication Date
2026-07-24

AI Technical Summary

Technical Problem

Existing technologies are insufficient for effectively separating and detecting utpatinib intermediate UPA-Z3 and its impurities, which affects drug quality and medication safety.

Method used

Reverse high performance liquid chromatography (RP-HPLC) was used with octadecylsilane-pentafluorophenyl alternating bonded silica gel as the packing material. Mobile phase A was 5 mmol/L-50 mmol/L phosphate buffer, and mobile phase B was methanol and/or acetonitrile. Upatinib intermediate UPA-Z3 and its impurities were separated by linear gradient elution, and the impurity content was calculated by combining detector detection and correction factors.

Benefits of technology

This technology enables efficient separation and quantitative detection of utpatinib intermediates and 10 impurities in a short time, ensuring controllable drug quality and improving drug safety.

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Abstract

The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a method for separating and detecting an upatinib intermediate UPA-Z3 and impurities thereof. The impurities comprise any one or more of an impurity Z1, an impurity Z1b, an impurity Z2, an impurity Z2d, an impurity Z3a, an impurity Z3b, an impurity Z3c, an impurity Z3d, an impurity Z3e and / or an impurity Z3f. A mobile phase is composed of a mobile phase A and a mobile phase B, the mobile phase A is a phosphate buffer solution with a concentration of 5-50 mmol / L, the mobile phase B is methanol and / or acetonitrile, and a chromatographic column adopts octadecylsilane pentafluorophenyl alternating bonded silica gel as a filling agent to carry out linear gradient elution of high performance liquid chromatography. Then, according to a chromatogram, the content of each impurity is calculated by adopting a main component self-contrast method multiplied by a correction factor. The method has the characteristics of good separation degree, good durability, high sensitivity and good reproducibility.
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