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

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

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-b...

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Hauptverfasser: LUO XIAOMEI, YUE WEIWEI, MAO RENGANG, ZHAO SHUJUN, ZHU YINFEI, GE KE
Format: Patent
Sprache:chi ; eng
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INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES
MEASURING
PHYSICS
TESTING
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creator LUO XIAOMEI
YUE WEIWEI
MAO RENGANG
ZHAO SHUJUN
ZHU YINFEI
GE KE
description 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 dissol
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subjects INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES
MEASURING
PHYSICS
TESTING
title High-performance liquid chromatography separation and determination method for related impurities in fosfomycin trometamol raw material drug and preparations thereof and application thereof
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