A detection method for determining racemic-3-n-butylphthalide related substances by HPLC
High performance liquid chromatography (HPLC) combined with specific chromatographic conditions and gradient elution procedures, the problem of difficult separation of multiple impurities in racemic-3-n-butylphenylene raw materials or preparations is solved, and efficient separation and detection is achieved, with good specificity, sensitivity and repeatability.
Patent Information
- Application Number
- CN202110937285.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2021-08-16
- Publication Date
- 2025-06-06
- Estimated Expiration
- 2041-08-16
AI Technical Summary
The existing detection methods for racemic-3-n-butylphthalide raw materials or preparation-related substances cannot effectively separate and detect various impurities produced during production and storage, especially the problem of racemic-3-n-butylphthalide overlapping with certain impurities peaks or poor resolution.
High performance liquid chromatography (HPLC) was used, and octadecylsilane bonded silica gel chromatography column was used, combined with specific mobile phase composition and gradient elution conditions, and the detection wavelength was 225-230 nm, the column temperature was 15℃-30℃, and the injection volume was 10-50μL. Racemic-3-n-butylphthalide and its related impurities were separated by linear gradient elution conditions.
It has achieved efficient separation of racemic-3-n-butylphthalide and various impurities, solved the problems of peak overlap and poor resolution, and has the advantages of good specificity, high sensitivity and good repeatability, and is suitable for quality control of racemic-3-n-butylphthalide raw materials and preparations.