Method for determination of related substances in mesalazine enemas

Abstract

The invention provides a method for determination of related substances in mesalazine enemas. In the method, high performance liquid chromatography is adopted, octadecyl silane bonded silica gel is used as column filler, a ultraviolet detector is adopted, appropriate organic phase, buffer solution and water are selected as mobile phase, and gradient elution is adopted to effectively solve the problem of separation between mesalazine and impurities. The method has high specificity, good repeatability and can ensure controllability of the process and degradation of the impurities in mesalazine.

Description

technical field [0001] The invention relates to the technical field of determining drug-related substances, in particular to a method for determining the related substances of mesalazine enema. Background technique [0002] Ulcerative colitis is a disease that exists all over the world. In recent years, the incidence of ulcerative colitis has been increasing in my country. Sulfasalazine (SASP) is often used in clinical treatment. Although it has a certain effect, its side effects The incidence rate is high, and those who are allergic to sulfonamides cannot apply it. Mesalazine was first successfully developed and put on the market by the German Hawker Pharmaceutical Factory. Compared with SASP, its main chemical structure is that it retains the active ingredient of 5-aminosalicylic acid and removes the sulfapyridine group, so it overcomes the limitations of SASP. The disadvantage is that it is a new drug for the treatment of ulcerative colitis, which has been widely used in ...

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Problems solved by technology

[0006] At present, USP, BP standards and import quality labels record the detection methods of mesalazine-related substances. Through the research on the detection methods, it is found that: ①USP standard adopts isocratic elution, which cannot completely separate the impurities in the mixed impurities; ②BP In the standard, the interference of the gradient peak at the position of the main peak and the impurity peak is obvious. Another chromatographic condition is used for impurity A and C alone, and perchloric acid is added to the mobile phase in the chromatographic condition for the detection of impurity A and C, which is easy to damage the chromatographic column;③ There are incomplete detection of impurities in the imported quality standards, and the separation degree of some impurities is not high, so accurate detection cannot be achieved

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