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

被引:16
作者
Anacleto, Sara da Silva [1 ]
Cordeiro Borges, Marcella Matos [1 ]
de Oliveira, Hanna Leijoto [1 ]
Vicente, Andressa Reis [2 ]
de Figueiredo, Eduardo Costa [3 ]
Leal de Oliveira, Marcone Augusto [4 ]
Pinheiro Borges, Barbara Juliana [5 ]
de Oliveira, Marcelo Antonio [6 ]
Borges, Warley de Souza [2 ]
Borges, Keyller Bastos [1 ]
机构
[1] Univ Fed Sao Joao del Rei, Dept Ciencias Nat, Campus Dom Bosco,Praca Dom Helvecio 74, BR-36301160 Sao Joao Del Rei, MG, Brazil
[2] Univ Fed Espirito Santo, Dept Quim, Ave Fernando Ferrari 514, BR-29075910 Vitoria, ES, Brazil
[3] Univ Fed Alfenas, Fac Ciencias Farmaceut, Lab Anal Toxicantes & Farmacos, Rua Gabriel Monteiro da Silva 700, BR-37130000 Alfenas, MG, Brazil
[4] Univ Fed Juiz de Fora, Dept Quim, Rua Jose Lourenco Kelmer S-N, BR-36036330 Juiz De Fora, MG, Brazil
[5] Univ Fed Espirito Santo, Ctr Ciencias Saude, Ave Marechal Campos 1468, BR-29043900 Vitori, ES, Brazil
[6] Univ Fed Espirito Santo, Ctr Univ Norte Espirito Santo, Br 101 Norte,Km 67, BR-2943900 Sao Mateus, ES, Brazil
关键词
HPLC; Physicochemical characterization; Quality control; Veterinary pharmaceutical formulation; Raw material; PERFORMANCE LIQUID-CHROMATOGRAPHY; PRIMARY METABOLITE CIPROFLOXACIN; HUMAN PLASMA; FLUORESCENCE DETECTION; BIOLOGICAL-FLUIDS; CAPILLARY-ELECTROPHORESIS; RAMAN-SPECTROSCOPY; LOCAL-ANESTHETICS; LC DETERMINATION; BOVINE-MILK;
D O I
10.1016/j.jpha.2018.01.001
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
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 C-18 (250 mm x 4.6 mm, 5 mu m) Phenomenex (R) column, at a temperature of 25 degrees 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. (C) 2018 Xi'an Jiaotong University. Production and hosting by Elsevier B.V.
引用
收藏
页码:168 / 175
页数:8
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