TLC-densitometric and first derivative spectrophotometric methods for determination of cefoxitin-sodium in presence of its alkali-induced degradation product

Khalid Abdel-Salam M. Attia , Omar Abdel-Aziz , Nancy Magdy , Ghada F. Mohamed
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引用次数: 4

Abstract

Two simple and accurate methods were developed for quantitative estimation of cefoxitin sodium in presence of its open ring alkali-induced degradation product. The first method was based on TLC separation of the drug from its alkali-induced degradation product followed by densitometric measurement of the intact drug at 254 nm. The proposed method obeys Beer’s law in range (1–20 µg/band). The second method was first derivative (1D) spectrophotometric method; was based on measurement of amplitude of first order spectra of cefoxitin sodium (in the range of 4–36 µg mL−1) at 282 nm which showed zero crossing point of its degradation product. The two methods were validated according to ICH guideline for accuracy, precision and were successfully applied for the determination of the drug in pure form and pharmaceutical preparation in presence of its alkali-induced degradation product.

用薄层色谱-密度法和一阶导数分光光度法测定头孢西丁钠碱降解产物的含量
建立了两种简便、准确的方法,用于头孢西丁钠开环碱降解产物的定量测定。第一种方法是采用薄层色谱法将药物与碱致降解产物分离,然后在254 nm处对完整药物进行密度测定。该方法在1 ~ 20µg/波段范围内符合Beer定律。第二种方法是一阶导数(1D)分光光度法;通过测定头孢西丁钠(4-36µg mL−1)在282 nm处的一阶光谱振幅,发现其降解产物的交叉点为零。根据ICH指南验证了两种方法的准确性和精密度,并成功地应用于该药物的纯制剂和碱诱导降解产物的测定。
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