The invention discloses a high-performance liquid
chromatography separation and determination method for impurities in a
fosfomycin trometamol
raw material drug and preparations thereof and an application thereof, aiming at separating the impurities. According to the method, the aminopropyl
silane-bonded
silica gel is used as a
chromatographic column of a filler, a differential
detector is used for detection; and a
phosphate buffer solution and
methanol-
acetonitrile are mixed as a mobile phase; the method includes the following steps of: 1, preparation of a
system suitability solution: wettinga
raw material drug or a preparation with water, heating, and dissolving and diluting the
raw material drug or the preparation by the mobile phase to obtain a solution A; dissolving and diluting theraw material drug or the preparation by using the solution A to obtain the
system suitability solution; 2, preparation of a
test solution: taking the raw material drug or the preparation, and adding the mobile phase for dissolving and
dilution to obtain the set content of
fosfomycin trometamol as the
test solution; 3, preparation of a reference solution: diluting the
test solution by using the mobile phase to obtain a solution containing
fosfomycin trometamol equivalent to a
mass concentration of 0.3-0.5% of the test solution as the reference solution; and 4, determination method: separately injecting the above three solutions into a liquid chromatograph, and calculating the content of each
impurity in the raw material drug by using a principal component self-control method.