Method for detecting oxcarbazepine and related substances in oxcarbazepine oral solution and quality control method
Patent Information
- Authority / Receiving Office
- CN Β· China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- WUHAN WUYAO SCI & TECH CO LTD
- Filing Date
- 2024-11-20
- Publication Date
- 2026-05-29
AI Technical Summary
Existing methods for detecting aminocaproic acid oral solution powder have problems such as poor impurity separation, insufficient specificity, low sensitivity, poor reproducibility, and high cost, making it difficult to meet the detection needs of the industry.
High performance liquid chromatography (HPLC) was used with phosphate solution and acetonitrile as the mobile phase. The concentration of phosphate solution was controlled between 0.1 mM and 10 mM. Gradient elution and a hydrophilic column were combined to separate and detect aminocapric acid and related substances.
It achieves high specificity, accuracy, sensitivity and stability for aminohexenoic acid and related substances, is easy to operate, and is suitable for a wide range of applications. The chromatographic peak resolution between the main peak and adjacent substances is not less than 1.5.
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