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Microbiological assay for azithromycin in pharmaceutical formulations.

A R Breier1, C V Garcia, T P Oppe

  • 1Departamento de Produção e Controle de Qualidade de Medicamentos, Universidade Federal do Rio Grande do Sul, Faculdade de Farmácia, Av. Ipiranga, 2752, -RS 90610-000, Porto Alegre, Brazil. anarita_breier@hotmail.com

Journal of Pharmaceutical and Biomedical Analysis
|July 3, 2002
PubMed
Summary

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A validated microbiological assay accurately quantifies the antibiotic azithromycin in various formulations. This method, using Micrococcus luteus, is reliable for determining in vitro antibacterial activity.

Area of Science:

  • Microbiology
  • Pharmaceutical Analysis

Background:

  • Accurate quantification of antibiotics is crucial for therapeutic efficacy and safety.
  • Microbiological assays offer a sensitive method for determining antibiotic potency.
  • Azithromycin is a widely used macrolide antibiotic requiring reliable analytical methods.

Purpose of the Study:

  • To validate a microbiological assay for determining azithromycin concentrations.
  • To establish the reliability of the cylinder-plate method for azithromycin analysis.
  • To assess the assay's suitability for pharmaceutical formulations.

Main Methods:

  • The cylinder-plate method was employed using Micrococcus luteus ATCC 9341 as the test organism.
  • Azithromycin concentrations ranging from 0.1 to 0.4 microg/mL were analyzed.

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  • Prospective validation included linearity, precision, and accuracy assessments.

    • Main Results:

    • The assay demonstrated excellent linearity (r=0.998).
    • High precision was observed across different formulations: capsules (RSD=1.40%), powder for suspension (RSD=1.19%), and oral suspension (RSD=1.73%).
    • The method accurately measured spiked quantities of azithromycin.

    Conclusions:

    • The validated microbiological assay is suitable for quantifying azithromycin.
    • This method effectively determines the in vitro antibacterial activity of azithromycin.
    • The cylinder-plate assay provides a reliable tool for pharmaceutical quality control of azithromycin.