DEVELOPMENT AND VALIDATION OF AN ECOLOGICAL, NEW AND RAPID STABILITY-INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR QUANTITATIVE DETERMINATION OF AZTREONAM IN LYOPHILIZED POWDER FOR INJECTION

Authors

  • Andressa Leme Figueiredo Universidade Estadual Paulista
  • Ana Carolina Kogawa Universidade Estadual Paulista
  • Hérida Regina Nunes Salgado Universidade Estadual Paulista http://orcid.org/0000-0002-0385-340X

DOI:

https://doi.org/10.22456/2527-2616.73755

Abstract

Aztreonam is a monocyclic synthetic antimicrobial with bactericidal activity against Gram-negative bacteria, the first agent from the monobactam family to be therapeutically approved. It was developed and validated analytical method using high performance liquid chromatography with UV detection at 292 nm to quantify the aztreonam. Furthermore, assessing stability through stress tests was carried out. The chromatographic separation was carried out by reverse phase on an Agilent C18 column (250 x 4.6 mm, 5 µm) with a mobile phase composed of water:ethanol (70:30, v/v) adjusted to pH 2.5 with acetic acid, pumped isocratically at a flow rate of 0.5 mL/min. The validation parameters linearity, selectivity, precision, accuracy, robustness, limits of detection and quantification were determined. The method proposed provides linear response within the concentration range of 45-95 µg/mL for aztreonam. Results obtained were found to be satisfactory. The proposed method is linear, accurate, precise, selective, and robust being able to quantify the aztreonam in raw material and in pharmaceutical preparations. The validated method was suitable for applications in quality control laboratories.

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Author Biography

Hérida Regina Nunes Salgado, Universidade Estadual Paulista

Departamento de Fármacos e Medicamentos

Faculdade de Ciências Farmacêuticas

Universidade Estadual Paulista

Rodovia Araraquara-Jau, km 1

CEP 14800-903

ARARAQUARA - SP

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Published

2017-08-28

How to Cite

Figueiredo, A. L., Kogawa, A. C., & Salgado, H. R. N. (2017). DEVELOPMENT AND VALIDATION OF AN ECOLOGICAL, NEW AND RAPID STABILITY-INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR QUANTITATIVE DETERMINATION OF AZTREONAM IN LYOPHILIZED POWDER FOR INJECTION. Drug Analytical Research, 1(1), p. 24–30. https://doi.org/10.22456/2527-2616.73755

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Section

ORIGINAL ARTICLES