A high performance liquid chromatography method for detecting related substances of celecoxib tramadol co-crystal tablets
By optimizing the gradient elution program and mobile phase composition, the high-performance liquid chromatography method solves the problem of low detection efficiency of impurities in celecoxib-tramadol co-crystal preparations, and realizes the simultaneous separation and quantification of celecoxib, tramadol hydrochloride and their impurities, meeting the requirements of drug quality control.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-05-26
- Publication Date
- 2026-07-17
AI Technical Summary
In the existing technology, the methods for detecting impurities in celecoxib-tramadol co-crystal preparations are inefficient and have poor specificity, which cannot meet the separation requirements of complex matrices in compound preparations, and it is difficult to achieve baseline separation of celecoxib and tramadol hydrochloride and their multiple impurities in the same chromatographic system.
High-performance liquid chromatography (HPLC) was employed to simultaneously separate and quantify celecoxib impurity A, celecoxib impurity B, tramadol hydrochloride impurity I, and other unknown single impurities by optimizing the gradient elution program and mobile phase composition. An octadecylsilane-bonded silica column was used. Mobile phase A consisted of potassium dihydrogen phosphate buffer and methanol, while mobile phase B consisted of methanol and acetonitrile. The detection wavelength was 215 nm.
It achieves complete separation of celecoxib and tramadol hydrochloride and their impurities on the same chromatographic column, doubling the detection efficiency, reducing costs, providing excellent separation, and delivering reliable results. It is suitable for drug quality control and meets pharmacopoeia requirements.
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