A method for detecting genotoxic impurities in galantamine hydrobromide
By optimizing the detection conditions using high-performance liquid chromatography, the problem of separating and detecting three genotoxic impurities in galantamine hydrobromide was solved, achieving simple, low-cost, and highly accurate detection to ensure drug safety.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- YANTAI VALIANT PHARM CO LTD
- Filing Date
- 2026-06-11
- Publication Date
- 2026-07-17
AI Technical Summary
Existing technologies struggle to simultaneously and efficiently separate and detect three genotoxic impurities in galantamine hydrobromide: ethyl p-toluenesulfonate, 1,2-propanediol p-toluenesulfonate, and 1,2-propanediol di-p-toluenesulfonate. Furthermore, the high concentration of the main peak of galantamine hydrobromide masks the impurity signal, resulting in a lack of effective detection methods.
High-performance liquid chromatography (HPLC) with a UV detector was used to separate and quantify ethyl p-toluenesulfonate, 1,2-propanediol p-toluenesulfonate, and 1,2-propanediol-di-p-toluenesulfonate in galantamine hydrobromide by optimizing chromatographic conditions such as mobile phase composition, gradient elution program, and column type.
This method enables the simultaneous detection of three genotoxic impurities in galantamine hydrobromide. It is simple, low-cost, highly selective, and accurate, making it suitable for quality control laboratories and ensuring drug safety.
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