Obeticholic acid and detection method for related substances in preparation of obeticholic acid
2017
The invention discloses an obeticholic acid and a detection method for related substances in a preparation of the obeticholic acid. The detection method includes the specific steps that the high performance liquid chromatography method is adopted, and a C18 column is adopted; a diode array detector is adopted, and the column temperature is 20 DEG C to 30 DEG C; a phosphate buffering liquid-acetonitrile-methyl alcohol solution serves as a moving phase for isocratic elution. By means of the detection method, the conditions of impurities and degradation products of the obeticholic acid can be rapidly and accurately detected, effective separation of the obeticholic acid and all known impurities can be achieved, the interference of all kinds of impurities generated in the synthesis and preparation processes of the obeticholic acid in the product purity is avoided, and the quality of raw material medicine and the quality of the preparation can be fully and reliably controlled. The detection method is easy and convenient to operate, high in sensitivity and good in separation degree, and an effectively analysis method is provided for controlling the quality of the product.
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