Abstract

Objective To establish a method for the analysis of related substances in sacubitril tablets. Methods SB-C18 (150 mm × 3.0 mm) column was used during the detection of its related substances. The mobile phase consisted of 0.05% trifluoroacetic acid in the pure water acid and 0.05% trifluoroacetic acid in acetonitrile. The mobile phase was eluted with gradient elution at a wavelength of 254 nm. Results The main peaks of sacubitril tablets could be completely separated from its four related substances. The content of total impurity in five batches of sacubitril tablets was less than 0.15%; and the other single impurity was not higher than 0.05%. Conclusion This method is the only one and can be used as a method for the detection of the related substances of sacubitril tablets Key words: Sacubitril tablets; Related substance; HPLC; Determination

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