Method for detecting related substances of ibuprofen and its sodium salt and preparation

Abstract

The invention provides a method for detecting related substances of ibuprofen or its sodium salt and preparation. The related substances comprise impurities A, B, C, D, E and F. The method comprises (1) preparation of a test sample solution: taking an appropriate amount of ibuprofen or ibuprofen sodium raw materials, putting the materials into a certain volume of a container, dissolving the materials, diluting the solution until a desired volume marked by a scale, shaking the solution, and filtering the solution to obtain a certain concentration of the test sample solution, and (2) sample detection: pouring the test sample solution into a chromatographic instrument, and acquiring a chromatogram map of the related substances separated effectively under chromatographic conditions of use of a chromatographic column containing octadecyl silane chemically bonded silica as a filler having size of 250*4.6mm and pore sizes of 5 micrometers and having a column temperature of 20 to 40 DEG C, use of a mobile phase having a volume ratio of organic phase acetonitrile to a water phase phosphoric acid aqueous solution of 32% to 48% and phosphoric acid content of 0.01 to 0.1% in the phosphoric acid aqueous solution, a flowing rate of 1.0 to 2.3 ml / min, and a detection wavelength of 205 to 225nm. The method can realize effective separation of a variety of impurities.

Description

technical field [0001] The invention belongs to the field of drug quality detection, in particular to a method for detecting related substances of ibuprofen, its sodium salt and preparations thereof. Background technique [0002] Ibuprofen is the only antipyretic drug for children jointly recommended by the World Health Organization and the US Federal Drug Administration (FDA), and is recognized as the first choice anti-inflammatory drug for children. Ibuprofen has anti-inflammatory, analgesic and antipyretic effects. It is slightly less effective than acetylsalicylic acid and phenylbutazone in the treatment of rheumatism and rheumatoid arthritis. It is suitable for the treatment of rheumatoid arthritis, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and neuritis, etc. However, ibuprofen sodium is more likely to reach a high blood concentration due to its good solubility. [0003] At present, the European Pharmacopoeia version 8.0 uses two systems of reverse...

AI Technical Summary

Problems solved by technology

The 2015 edition of the Chinese Pharmacopoeia and the 16th edition of the Japanese Pharmacopoeia both use thin-layer chromatography to check the related substances in ibuprofen, but this method cannot achieve accurate qualitative and quantitative impurities, and only roughly checks the impurities in ibuprofen

[0005] In addition, the detection method for ibuprofen sodium salt has not been recorded or reported in the pharmacopoeias or literatures of various countries.

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