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Abstract
abstract Daptomycin (DPT) was the first lipopeptide antibiotic available for commercialization. It is active against gram-positive bacteria, including resistant strains. This work aimed to develop and validate a turbidimetric microbiologic assay to determine daptomycin in an injectable form. A 3x3 design was employed, at concentrations of 1, 2 and 4.0 µg/mL. The microorganism test used was Staphylococcus aureus ATCC 6538p, and Antibiotic Medium 3 was used as the culture medium. Method validation demonstrated that the bioassay was linear (r=0.9995), precise (RSD=2.58%), accurate (recovery 100.48± 2.11%), and robust. Degradation kinetics was also performed in an alkaline medium, indicating that daptomycin degradation follows first order kinetics under these conditions. The analyses of degraded solutions showed that daptomycin degradation products do not possess bactericidal activity. The bioassay was compared to HPLC method that was previously developed and no significant difference was found between them (p>0.05). The method proved to be appropriate for daptomycin injection quality control.
Highlights
ObjectivesThis work aimed to develop and validate a turbidimetric microbiologic assay to determine daptomycin in an injectable form
When the first antibiotics, such as penicillin, began to be used in clinical medicine, around 1940, they were considered miracle drugs because they were ableA
The potency of antibiotics in pharmaceuticals can be assessed by a cylinder-plate assay and the turbidimetric assay
Summary
This work aimed to develop and validate a turbidimetric microbiologic assay to determine daptomycin in an injectable form. The aim of this study was to develop and validate a simple, specific, accurate, reproducible, and stabilityindicative turbidimetric microbiological assay to quantify injectable daptomycin
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