头孢克肟的红外光谱、高效液相色谱和气相色谱分析与表征

M. P. Rao, B. R. Rao, M. Srikanth
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引用次数: 1

摘要

目的:建立一种简便、灵敏、准确、经济的头孢克肟制剂中相关化合物的分析方法。根据USP、欧洲和ICH指南对拟用于分析的方法进行验证。用红外光谱法和溶解度法鉴定样品是否为头孢克肟。用红外光谱法测定给定样品在cm-1(波长区倒数)的波数。用卡尔费希尔法测定头孢克肟样品中的水分含量。采用高效液相色谱法,对头孢克肟的含量及相关物质(杂质)进行测定。用气相色谱法估计残余溶剂的量。试验按照欧洲头孢克肟专论的要求进行。关键词:头孢克肟;红外光谱;高效液相色谱
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Analysis and characterization of cefixime by using IR, HPLC and gas chromatography
To develop a new, simple, sensitive, accurate, and economical analytical methods for the estimation of related compounds in Cefixime formulations. Validate the proposed methods in accordance with USP, EUROPE and ICH guidelines for the intended analytical application. Identify whether the given sample is Cefixime by IR spectroscopy and solubility test. To determine the wavenumber in cm-1 (reciprocal to wave length region) of given sample by Infrared Spectroscopy. To determine the moisture content present in the given sample of Cefixime by Karl Fischer method. Find out the assay and related substances (impurities) of given Cefixime by using the validated method with help of High performance Liquid Chromatography. Estimate the amount of Residual solvents by Gas Chromatography. The tests were performed as per the requirements of EUROPE monograph for Cefixime. Keywords: Cefixime, IR, HPLC and gas chromatography
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