The invention discloses a method for detecting an
impurity I in an
amikacin sulfate injection, which adopts a sulfonic strong
ion exchange
chromatographic column and a specific
buffer solution for
gradient elution, and can realize high-sensitivity detection without an
ampere detector. Wherein a
chromatographic column adopts a
sulfonyl strong cation
sodium system exchange column,
gradient elution is performed by using a mobile phase, the mobile phase consists of a first
buffer solution, a second
buffer solution and a regeneration solution, and the first buffer solution is a
citrate buffer solution I; the second buffer solution is a
citrate buffer solution II; the regeneration liquid is an
ethylenediaminetetraacetic acid sodium hydroxide solution. By screening and optimizing chromatographic conditions such as flow velocity, temperature,
wavelength and the like, accurate quantitative detection of the
impurity is realized. According to systematic methodology
verification, the method has the advantages of high specificity, high sensitivity, good precision, high accuracy and the like, and the
impurity I in the
amikacin sulfate injection can be quantitatively or qualitatively detected, so that the safety of clinical medication of the
amikacin sulfate injection is improved.