Microbiological assay for azithromycin in pharmaceutical formulations

被引：49

作者：

Breier, AR ^{[1
]}

Garcia, CV ^{[1
]}

Oppe, TP ^{[1
]}

Steppe, M ^{[1
]}

Schapoval, EES ^{[1
]}

机构：

[1] Univ Fed Rio Grande Sul, Fac Farm, Dept Prod & Controle Qualidade Medicamentos, BR-90610000 Porto Alegre, RS, Brazil

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2002年 / 29卷 / 05期

关键词：

azithromycin; microbiological assay; cylinder-plate method; micrococcus luteus;

D O I：

10.1016/S0731-7085(02)00213-3

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

The validation of a microbiological assay, applying the cylinder-plate method, for the determination of the antibiotic azithromycin is described. Using a strain of Micrococcus luteus ATCC 9341 as the test organism, azithromycin at concentrations ranging from 0.1 to 0.4 mug ml (-1) could be measured in capsules and suspensions. A prospective validation of the method showed that it was linear (r = 0.998), precise (RSD = 1.40-capsules; RSD = 1.19-powder for suspension and RSD = 1.73-oral suspension) and accurate (it measured the added quantities). We conclude that the microbiological assay is satisfactory for quantitation of in vitro antibacterial activity of azithromycin. (C) 2002 Elsevier Science B.V. All rights reserved.

引用

页码：957 / 961

页数：5

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