Liquid chromatographic determination of cephalexin preparations: Interlaboratory validation

被引：9

作者：

Hsu, MC ^{[1
]}

Chung, HC ^{[1
]}

Lin, YS ^{[1
]}

机构：

[1] DEPT HLTH,NATL LABS FOODS & DRUGS,TAIPEI 11513,TAIWAN

来源：

JOURNAL OF CHROMATOGRAPHY A | 1996年 / 727卷 / 02期

关键词：

interlaboratory validation; cephalexin; acetaminophen; antibiotics;

D O I：

10.1016/0021-9673(95)01119-6

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

A previously published column liquid chromatographic method proposed for the analysis of cephalexin preparations was subjected to an interlaboratory validation. The method was rigorously defined in terms of performance requirements, yet allowed a degree of flexibility to the individual analyst. Nine participating laboratories submitted results for the analysis of bulk drug substance, capsules and powder for oral suspension. Estimates of the within-laboratory standard deviation, the between-laboratories standard deviation, repeatability relative standard deviation and reproducibility relative standard deviation of the results of the analysis of cephalexin preparations were found to be 0.34, 2.01, 0.32 and 1.94%, respectively.

引用

页码：239 / 244

页数：6