Desenvolvimento e validação de método analítico titulométrico para o  controle de qualidade de levofloxacino em comprimidos

Mirella Carla Galana Gerlin; Patrícia Espinosa dos Santos; Teófilo Fernando Mazon Cardoso; Marcos Serrou do Amaral; Nájla Mohamad Kassab

doi:10.22481/exon.v13i1.20560

Authors

Mirella Carla Galana Gerlin Universidade Federal de Mato Grosso do Sul
Patrícia Espinosa dos Santos Universidade Federal de Mato Grosso do Sul
Teófilo Fernando Mazon Cardoso Universidade Federal de Mato Grosso do Sul
Marcos Serrou do Amaral Universidade Federal de Mato Grosso do Sul
Nájla Mohamad Kassab Universidade Federal de Mato Grosso do Sul

DOI:

https://doi.org/10.22481/exon.v13i1.20560

Keywords:

Levofloxacin, Fluoroquinolone, Quality Control, Validation, Titrimetric, Pharmaceutical analysis

Abstract

Levofloxacin is a broad-spectrum antimicrobial agent used for the treatment of respiratory infections. Considering the high consumption of this antimicrobial, it is essential to perform quality control to ensure safety and efficacy, since quality deviations can harm the health of patients and contribute to the emergence of bacterial resistance. For the determination and quality control of levofloxacin, several analytical methods are described in the literature, employing high-performance liquid chromatography and spectrophotometry. In this study, a novel procedure for an environmentally friendly analytical method is proposed, which does not require the use of a toxic solvent or expensive equipment. Using ethanol as dissolution medium to the drug, and sodium hydroxide as titrant. The validation was carried out following ANVISA Resolution 166/2017. The developed method was satisfactory in linearity, precision, accuracy, robustness, and selectivity tests. Furthermore, it proved to be sensitive, with a quantification limit of 2.77 mg. The titrimetric method developed was compared to a previously validated spectrophotometric method, and both presented similar results in the dosage of the drug in tablets, proving the efficiency of the proposed method. In addition, it is economical, fast, does not require costly equipment, and avoids the use and disposal of very toxic solvents.

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