New approaches of identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms

Publication date: Available online 23 November 2018Source: Journal of Pharmaceutical AnalysisAuthor(s): Natalia L. Calvo, Vera A. Alvarez, María C. Lamas, Darío LeonardiAbstractTioconazole, a broad-spectrum antifungal agent, has significant activity against Candida albicans and other Candida species, and therefore, it is indicated for the topical treatment of superficial mycoses. The main goal of this work is to report an exhaustive identification and characterization procedure to improve and facilitate the on line quality control and continuous process monitoring of tioconzole in bulk material and loaded in two different dosage forms: ovules and nail lacquer. The methodologies were based on thermal (differential scanning calorimetry (DSC), melting point, and thermogravimetry(TG)), spectroscopic (ultraviolet (UV), RAMAN, near infrared (NIR), infrared spectroscopy coupled to attenuated total reflectance (FTIR-ATR), and nuclear magnetic resonance (NMR)), microscopic and X-ray diffraction (XRD). The tioconzole bulk powder showed a high crystallinity, as observed by XRD, with a particles size distribution (3–95 μm) resolved by microscopic measurements. Tioconazole melting point (82.8 °C) and a degradation peak centered at 297.8 °C were obtained by DSC and DTG, respectively. An unambiguous structure elucidation of tioconazole was obtained by mono- and two- dimensional 1H and 13C NMR spectral data analysis. The FTIR-ATR, RAMAN and NIR spectra of both the raw materi...
Source: Journal of Pharmaceutical Analysis - Category: Drugs & Pharmacology Source Type: research