Stability-indicating HPLC-DAD method for the simultaneous determination of fluoroquinolone in combination with a non-steroidal anti-inflammatory drug in pharmaceutical formulation



Document title: Stability-indicating HPLC-DAD method for the simultaneous determination of fluoroquinolone in combination with a non-steroidal anti-inflammatory drug in pharmaceutical formulation
Journal: Brazilian Journal of Pharmaceutical Sciences
Database: PERIÓDICA
System number: 000451459
ISSN: 1984-8250
Authors: 1
2
3
2
2
4
2
Institutions: 1Universidade Federal do Mato Grosso do Sul, Hospital Universitario Maria Aparecida Pedrossian, Campo Grande, Mato Grosso do Sul. Brasil
2Universidade Federal do Mato Grosso do Sul, Faculdade de Ciencias Farmaceuticas, Campo Grande, Mato Grosso do Sul. Brasil
3Universidade Federal do Mato Grosso do Sul, Instituto de Fisica, Campo Grande, Mato Grosso do Sul. Brasil
4Universidade Federal do Mato Grosso do Sul, Instituto de Quimica, Campo Grande, Mato Grosso do Sul. Brasil
Year:
Volumen: 56
Country: Brasil
Language: Inglés
Document type: Artículo
Approach: Experimental, aplicado
English abstract We developed and validated a stability-indicating assay method for the simultaneous determination of enrofloxacin and piroxicam in combination and in the presence of degradation products. Reverse-phase high-performance liquid chromatography analyses were carried out on a Vertisep C18 column and acetonitrile-water (48:52 v/v, pH 3.0) mobile phase with a 1.00 mL min−1 flow rate. The efficient chromatographic separation of these drugs and their forced degradation products was achieved in less than 5min with a peak purity match factor higher than 950. The method used showed linearity in the concentration ranges of 0.25 to 16.0 µg mL−1 for enrofloxacin (r = 0.9997) and 0.125 to 8.0 µg mL−1 for piroxicam (r = 0.9999) as well as precision (relative standard deviation lower than 2%), accuracy (mean recovery 100 ± 2%), and robustness, according to ICH (International Conference on Harmonization) and AOAC (Association of Official Analytical Chemists) guidelines. This method can simultaneously determine the combination of these drugs in a veterinary formulation and separate the drug peaks from their forced degradation products. Additionally, its optimized chromatographic conditions can contribute to the quality control of this formulation in pharmaceutical manufacturing plants and minimize waste from the organic solvent
Disciplines: Química
Keyword: Química farmacéutica,
Química analítica,
Antiinflamatorios,
Formulaciones farmacéuticas,
Enrofloxacina,
Piroxicam,
Fluoroquinolonas,
Cromatografía líquida de alta resolución (HPLC),
Estabilidad química
Keyword: Medicinal chemistry,
Analytical chemistry,
Antiinflammatory agents,
Pharmaceutical formulations,
Enrofloxacin,
Piroxicam,
Fluoroquinolones,
High performance liquid chromatography (HPLC),
Chemical stability
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