Analysis method for determining genotoxic impurities in nilotinib composition

The detection method for nilotinib compositions was optimized by liquid chromatography, which solved the problem of difficulty in detecting low-concentration impurity A in the prior art. It achieved low-cost and high-sensitivity detection of impurity A and is suitable for the quality control of nilotinib capsules and suspensions.

CN122259727APending Publication Date: 2026-06-23SHANDONG BESTCOMM PHARMA CO LTD
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Patent Information

Application Number
CN202411874449.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-19
Publication Date
2026-06-23

AI Technical Summary

Technical Problem

Existing technologies cannot effectively detect low concentrations of genotoxic impurity A in nilotinib formulations, and conventional methods are either costly or lack sufficient sensitivity, making it difficult to meet the quality control requirements of large-scale production.

Method used

Liquid chromatography was used to separate impurity peak A by adjusting the pH of the nilotinib composition to 1.0–3.0, using a specific ratio of organic solvent and aqueous solution to precipitate suspended solids, and diluting to ≤30% organic solvent content. Combined with a UV detector and gradient elution, the chromatographic conditions were optimized.

Benefits of technology

It achieves low-cost, high-sensitivity detection of impurity A, avoids column damage, and is suitable for quality control of nilotinib capsules, suspensions, and other compositions. It has low detection cost, good specificity, and strong applicability.

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Abstract

The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to an analysis method for determining genotoxic impurities in a nilotinib composition. The method has the advantages of being good in specificity, easy and convenient to operate, high in sensitivity, low in cost, suitable for frequent detection in large-scale production and the like when being used for measuring the impurity A in compositions such as nilotinib oral suspension, nilotinib dry suspension or nilotinib capsules, the method can effectively separate the peak of the nilotinib impurity A and the adjacent impurity peak of the nilotinib impurity A, and the purity of the nilotinib impurity A is greatly improved. And the problem that the chromatographic column is easy to damage in the nilotinib impurity A determination process is solved.
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