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用于测定药物剂型中头孢他啶的分光光度法的开发与验证。

Development and validation of spectrophotometric methods for determination of ceftazidime in pharmaceutical dosage forms.

作者信息

Hiremath Basavaraj, Mruthyunjayaswamy Bennikallu Hire Mathada

机构信息

Department of Chemistry, Gulbarga University, Gulbarga-585106, India.

出版信息

Acta Pharm. 2008 Sep;58(3):275-85. doi: 10.2478/v10007-008-0017-0.

DOI:10.2478/v10007-008-0017-0
PMID:19103564
Abstract

Two spectrophotometric methods for the determination of ceftazidime (CFZM) in either pure form or in its pharmaceutical formulations are described. The first method is based on the reaction of 3-methylbenzothiazolin-2-one hydrazone (MBTH) with ceftazidime in the presence of ferric chloride in acidic medium. The resulting blue complex absorbs at lambdamax 628 nm. The second method describes the reaction between the diazotized drug and N-(1-naphthyl)ethylenediamine dihydrochloride (NEDA) to yield a purple colored product with lambdamax at 567 nm. The reaction conditions were optimized to obtain maximum color intensity. The absorbance was found to increase linearly with increasing the concentration of CFZM; the systems obeyed the Beer's law in the range 2-10 and 10-50 microg mL-1 for MBTH and NEDA methods, resp. LOD, LOQ and correlation coefficient values were 0.15, 0.79 and 0.50, 2.61. No interference was observed from common excipients present in pharmaceutical formulations. The proposed methods are simple, sensitive, accurate and suitable for quality control applications.

摘要

本文描述了两种分光光度法,用于测定纯头孢他啶(CFZM)或其药物制剂中的头孢他啶。第一种方法基于在酸性介质中,3 - 甲基苯并噻唑啉 - 2 - 酮腙(MBTH)与头孢他啶在氯化铁存在下的反应。生成的蓝色络合物在628 nm处有最大吸收波长。第二种方法描述了重氮化药物与N - (1 - 萘基)乙二胺二盐酸盐(NEDA)之间的反应,生成一种在567 nm处有最大吸收波长的紫色产物。对反应条件进行了优化以获得最大颜色强度。发现吸光度随CFZM浓度的增加呈线性增加;对于MBTH和NEDA方法,体系分别在2 - 10和10 - 50 μg mL-1范围内符合比尔定律。检测限、定量限和相关系数值分别为0.15、0.79和0.50、2.61。未观察到药物制剂中常见辅料的干扰。所提出的方法简单、灵敏、准确,适用于质量控制应用。

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