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Microbiological Antibiotic Assay Validation of Gentamicin Sulfate Using Two-Dose Parallel Line Model (PLM)

Mostafa Essam Eissa, Engy Refaat Rashed, Dalia Essam Eissa

Abstract


Nowadays, microbiological assay is still widely used with several antibiotics that are composed of a mixture of related active compounds. However, obtaining a reasonably valid determination of the potency is dependent on the validity and suitability of the assay design. The present work aimed to validate an assay design for an aminoglycoside antibiotic (Gentamicin Sulfate) using a two-dose Parallel Line Model agar diffusion assay in a large 8×8 rectangular plate. All preparatory procedures were done following the United States Pharmacopeia and the inhibition zones were measured using a digital caliper to the nearest 0.01 mm. Analysis of variance in compendial requirements for regression and parallelism were found to satisfactorily meet the acceptance criteria. Specificity was achieved for the product under investigation with no detectable IZ that could be found for all components except the antibiotic. The validation method showed an acceptable linearity of r2≥0.98. Accuracy and precision parameters showed RSD (%)<2. All relative error value estimates were below 4%. The proposed validation design for 32×32 cm antibiotic plates yielded valid results and can be projected for the routine Quality Control analysis of the antibiotic material, especially that which is incorporated into a finished medicinal dosage form.

 

Doi: 10.28991/HIJ-2021-02-04-04

Full Text: PDF


Keywords


Gentamicin Sulfate; Biotechnology; PLM; Parallelism; Linearity; Precision; Ruggedness; Agar Diffusion; Inhibition Zone.

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DOI: 10.28991/HIJ-2021-02-04-04

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