Evaluation of physicochemical properties as supporting information on quality control of raw materials and veterinary pharmaceutical formulations

• Published in: Journal of pharmaceutical analysis 2018-06, Vol.8 (3), p.168-175
• Main Authors: Anacleto, Sara da Silva, Borges, Marcella Matos Cordeiro, de Oliveira, Hanna Leijoto, Vicente, Andressa Reis, de Figueiredo, Eduardo Costa, de Oliveira, Marcone Augusto Leal, Borges, Bárbara Juliana Pinheiro, de Oliveira, Marcelo Antonio, Borges, Warley de Souza, Borges, Keyller Bastos
• Format: Article
• Language: English
• Subjects: Acetonitrile; Antibiotics; Bacterial infections; Capillary electrophoresis; Chromatography; Ciprofloxacin; Drugs; Enrofloxacin; Fourier transforms; High-performance liquid chromatography; HPLC; Infections; Infrared spectroscopy; Lidocaine; Mass spectrometry; Methods; Microscopy; Original; Pathogens; Pharmaceuticals; Phosphoric acid; Physicochemical characterization; Physicochemical properties; Quality control; Raw material; Raw materials; Scientific imaging; Studies; Veterinary medicine; Veterinary pharmaceutical formulation
• ISSN: 2095-1779; 2214-0883
• DOI: 10.1016/j.jpha.2018.01.001

This study aimed to show that the physicochemical proprieties obtained by Fourier transform infrared spectroscopy (FTIR), thermogravimetry (TG), and scanning electronic microscopy (SEM) can be useful tools for evaluating the quality of active pharmaceutical ingredients (APIs) and pharmaceutical products. In addition, a simple, sensitive, and efficient method employing HPLC-DAD was developed for simultaneous determination of lidocaine (LID), ciprofloxacin (CFX) and enrofloxacin (EFX) in raw materials and in veterinary pharmaceutical formulations. Compounds were separated using a Gemini C18 (250 mm × 4.6 mm, 5 µm) Phenomenex® column, at a temperature of 25 °C, with a mobile phase containing 10 mM of phosphoric acid (pH 3.29): acetonitrile (85.7:14.3, v/v) and a flow rate of 1.5 mL/min. Physicochemical characterization by TG, FTIR, and SEM of raw materials of LID, CFX, and EFX provided information useful for the evaluation, differentiation, and qualification of raw materials. Finally, the HPLC method was proved to be useful for evaluation of raw material and finished products, besides satisfying the need for an analytical method that allows simultaneous determination of EFX, CFX, and LID, which can also be extended to other matrices and applications. [Display omitted] •FTIR, TGA, and SEM are useful tools for the evaluation of the quality of APIs.•A RP-HPLC method was developed and validated for the determination of LID, CFX, EFX.•The proposed RP-HPLC method showed precise and accurate results in quality control.•This method can be applied to the analysis of veterinary pharmaceutical products.