High-performance liquid chromatography separation and determination method for related impurities in fosfomycin trometamol raw material drug and preparations thereof and application thereof

Abstract

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.

Description

technical field

[0001] The invention belongs to the technical field of medicine, and relates to a method for separation and determination of drug-related substances and its application, in particular to a high-performance liquid chromatography method for separation and determination of related impurities in fosfomycin trometamol raw material medicine and its preparation and its application . Background technique

[0002] Fosfomycin trometamol, the English name is Fosfomycin Trometamol, the chemical name is (1R,2S)-(1,2-epoxypropyl)phosphonic acid·2-amino-2-(hydroxymethyl)-1, 3-propanediol salt (1:1), the chemical formula is C 7 h 18 NO 7 P, the molecular weight is 259.20, the CAS number is 78964-85-9, and the structural formula is as follows:

[0003]

[0004] The indication of fosfomycin trometamol is the treatment of acute simple lower urinary tract infection caused by sensitive bacteria (such as: acute cystitis, acute exacerbation of chronic cystitis, acute urethra...

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