科研之友
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摘要
Six, sensitive, precise and accurate methods have been developed for the determination of cefditoren pivoxil (CP). The first two methods were based on the formation of charge transfer colored complex between CP and p-chloranilic acid (p-CA) or 2,3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ) in the concentration range of 50.00-225.00 mu g mL(-1) and 75.00-250.00 mu g mL(-1), respectively. The influence of different parameters on color formation was studied to determine optimum conditions for the visible spectrophotometric methods. The other four methods were adopted for determination of the studied drug in the presence of its acid degradation products including two spectrophotometric methods, namely, first derivative (D-1) and first derivative of ratio spectra (DD1), and two chromatographic methods, namely, thin-layer chromatography (TLC) and high-performance liquid chromatography (HPLC), as stability-indicating techniques. The degradation products were identified by infrared and mass spectroscopy. All the proposed methods were validated and successfully applied for determination of CP in pure form and in pharmaceutical preparations with good recovery ranges between 99.19 and 100.62. The results obtained by applying the proposed methods were statistically analyzed and compared with those obtained by the manufacturer method, and no significant difference was found.
- 出版日期2013-2
