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

• Main Authors: Sara da Silva Anacleto, Marcella Matos Cordeiro Borges, Hanna Leijoto de Oliveira, Andressa Reis Vicente, Eduardo Costa de Figueiredo, Marcone Augusto Leal de Oliveira, Bárbara Juliana Pinheiro Borges, Marcelo Antonio de Oliveira, Warley de Souza Borges, Keyller Bastos Borges
• Format: Article
• Language: English
• Published: Elsevier 2018-06-01
• Series: Journal of Pharmaceutical Analysis
• Online Access: http://www.sciencedirect.com/science/article/pii/S2095177918300017

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. Keywords: HPLC, Physicochemical characterization, Quality control, Veterinary pharmaceutical formulation, Raw material