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A fully validated microbiological assay for daptomycin injection and comparison to HPLC method BJPS
Christ,Ana Paula; Machado,Mariana Souto; Ribas,Karla Giacomelli; Schwarzbold,Alexandre Vargas; Silva,Cristiane de Bona da; Adams,Andréa Inês Horn.
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...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Daptomycin/determination; Daptomycin injection/quality control; Turbidimetric microbiological assay/quantitative analysis..
Ano: 2015 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000400775
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A green approach for the quantification of daptomycin in pharmaceutical formulation by UV spectrophotometry BJPS
Tótoli,Eliane Gandolpho; Salgado,Hérida Regina Nunes.
abstract Daptomycin is the first approved drug from a new class of antimicrobials, the cyclic lipopeptides, and is a very important antimicrobial agent in current clinical practice. Currently, there are no "green" analytical methods described in the literature to analyze the typical pharmaceutical dosage form of daptomycin. Thus, the aim of this work was to validate an environment-friendly spectrophotometric method in the UV region, for the analysis of daptomycin as a lyophilized powder. Water was used as diluent and the analyses were carried out on a spectrophotometer at 221 nm. The method met all validation requirements of the ICH guidelines, over a concentration range of 6-21 µg mL-1. A Student's t-test demonstrated that the proposed method was...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Antimicrobials/quality control; Daptomycin/determination; Spectrophotometry/UV region/quantitative analysis; Spectrophotometry/green analytical method.
Ano: 2015 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000400811
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