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藥物食品檢驗局調查研究年報

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篇名 High-performance liquid chromatographic method for potency determination of cephalexin in commercial preparations and for stability studies
卷期 13
作者 Mei-Chich Hsua 、 Yu-Shan Linb 、 Hsiou-Chuan Chung
頁次 030-035
關鍵字 TSCI
出刊日期 199509

中文摘要

英文摘要

A reversed-phase column liquid chromatographic method was developed for the assay of cephalexin in bulk drugs and pharmaceutical preparations. An equation was derived showing a linear relationship between peak-area ratio of cephalexin to acetaminophen (internal standard) and the cephalexin concentration over a range of 0.2-1.75 mg/ml (r = 0.9999). Standard addition recoveries were generally greater than 99.5%. The relative standard deviations were between 0.38 and 0.63% in the within-day assay, and 1.05% in the between-day assay. The column liquid chromatographic assay results were compared with those obtained from a microbiological assay, which indicated that the proposed method is a suitable substitute for the microbiological method for potency assays and stability studies of cephalexin preparations.

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