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

Abstract

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.

Fourier-transformed infrared spectroscopy, physicochemical and biochemical properties of chondroitin sulfate and glucosamine as supporting information on quality control of raw materials

“…However, analytical analyses of results' assessment, even in compliance, were able to identify different products and manufacturers with a trend toward the lower tolerance limits. Because the preparations of CS, whether or not they are combined with GlcN, present extensive chemical variations depending on their animal source [4,12,14,[26][27][28], it is necessary to establish a comprehensive set of analytical protocols to assess the fine structure, physicochemical characteristics, and purity of each type of CS and GlcN present in these pharmaceutical products. In the present study, we evaluated the physicochemical parameters of two raw materials used in pharmaceutical formulations for osteoarthritis treatment (CS and GlcN) in compounding pharmacy, according to Brazilian pharmacopeia specifications and analytical data from post-marketing and recognized by ANVI SA [20], and compared the obtained data with the product specification report provided by the manufacturer.…”

Bilayer Mucoadhesive Buccal Film for Mucosal Ulcers Treatment: Development, Characterization, and Single Study Case

“…The FTIR spectra of drugs and mucoadhesive films are shown in Figure 6. The FTIR spectrum of lidocaine HCl shows O-H stretching and hydrogen bonding intermolecular at 3500 cm −1 , only alkenes and aromatics show a C-H stretch slightly higher at 3000 cm −1 , a C-O stretching acid group at 1650 cm −1 , N-H stretching at 3451, 3385, and 1550 cm −1 , a C=O stretch carbonyl group at 1475 cm −1 , and O-H bending at 1250 cm -1 [32]. The typical functional groups of N-acetyl-L-cysteine are all well identifiable with full bands in the spectrum.…”

Implementasi Manajemen Risiko pada Cold Room Penyimpanan Bahan Baku Produk Biologi Farmasi Sebagai Langkah Penjaminan Kualitas

“…Selama pengembangan produk biologi farmasi sangat penting untuk mengetahui sifat dan kondisi penyimpanan dari bahan baku yang akan digunakan [5]. Hal tersebut dikarenakan kualitas produk sangat bergantung pada kondisi lingkungan penyimpanan.…”