HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC METHOD FOR POTENCY DETERMINATION OF CEPHALEXIN IN COMMERCIAL PREPARATIONS AND FOR STABILITY STUDIES

被引:20
作者
HSU, MC [1 ]
LIN, YS [1 ]
CHUNG, HC [1 ]
机构
[1] DEPT HLTH,NATL LABS FOODS & DRUGS,TAIPEI 11513,TAIWAN
关键词
D O I
10.1016/0021-9673(94)00688-6
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
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.
引用
收藏
页码:67 / 72
页数:6
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