A fully validated microbiological assay for daptomycin injection and comparison to HPLC method

Authors

  • Ana Paula Christ Federal University of Santa Maria; Department of Industrial Pharmacy
  • Mariana Souto Machado Federal University of Santa Maria; Department of Industrial Pharmacy
  • Karla Giacomelli Ribas Federal University of Santa Maria; Department of Industrial Pharmacy
  • Alexandre Vargas Schwarzbold Universitary Hospital of Santa Maria
  • Cristiane de Bona da Silva Federal University of Santa Maria; Department of Industrial Pharmacy
  • Andréa Inês Horn Adams Federal University of Santa Maria; Department of Industrial Pharmacy

DOI:

https://doi.org/10.1590/S1984-82502015000400003

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.

Downloads

Download data is not yet available.

Downloads

Published

2015-12-01

Issue

Section

Articles

How to Cite

A fully validated microbiological assay for daptomycin injection and comparison to HPLC method . (2015). Brazilian Journal of Pharmaceutical Sciences, 51(4), 775-783. https://doi.org/10.1590/S1984-82502015000400003