Method for detecting raw materials and auxiliary materials in dexketoprofen trometamol oral solution

CN121208196APending Publication Date: 2025-12-26YUANFANG NEW DRUG (BEIJING) TECHNOLOGY CO LTD
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Patent Information

Application Number
CN202511466700.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-10-14
Publication Date
2025-12-26

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Abstract

The invention belongs to the technical field of pharmaceutical preparation analysis, and relates to a method for detecting raw materials and auxiliary materials in a dexketoprofen trometamol oral solution. The invention discloses a method for detecting raw materials and auxiliary materials in a dexketoprofen trometamol oral solution. Dexketoprofen, methylparaben, ammonium glycyrrhizinate, neohesperidin dihydrochalcone, saccharin sodium salt and lemon essence in the dexketoprofen trometamol oral solution are quantitatively detected by adopting high performance liquid chromatography. Wherein the high performance liquid chromatography conditions are as follows: an octadecyl silane bonded silica gel column is taken as a chromatographic column, a phosphoric acid solution is taken as a mobile phase A, acetonitrile or methanol is taken as a mobile phase B, the detection wavelength is 255 + / -5nm, and gradient elution is adopted. The detection method disclosed by the invention can be used for effectively separating small molecular substances with ultraviolet absorption in the dexketoprofen trometamol oral solution, including dexketoprofen trometamol, the five auxiliary materials and other components contained in the oral solution, so that the content of dexketoprofen trometamol and the five auxiliary materials can be accurately detected.
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