Thermoanalytical Study and Purity Determination of Azelastine Hydrochloride and Emedastine DifumarateSawsan A Abdel-Razeq1, Nahla N Salama2*, Shimaa Abdel-Atty2 and Naglaa El-Kosy2
- *Corresponding Author:
- Nahla N Salama
Department of Analytical Chemistry and Raw Materials
National Organization for Drug Control and Research
Giza, Egypt, 6 Abu Hazem St.
Pyramids, Ave, P. O. Box 29
Tel: 202-02 35851299
Fax: 202-02 35855582
E-mail: [email protected]
Received date: Septemer 21, 2012; Accepted date: October 17, 2012; Published date: October 21, 2012
Citation: Abdel-Razeq SA, Salama NN, Atty SA, Kosy NE (2012) Thermoanalytical Study and Purity Determination of Azelastine Hydrochloride and Emedastine Difumarate. Pharmaceut Anal Acta 3:176. doi: 10.4172/2153-2435.1000176
Copyright: © 2012 Abdel-Razeq, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
The thermal behavior of antihistaminic drugs, azelastine hydrochloride, and emedastine difumarate in their drug substances were investigated using different thermal techniques. The thermogravimetry was used to study the thermal degradation and kinetic parameters; activation energy (Ea), frequency factor (A), and reaction order (n) of both drugs. The data revealed that the cited drugs followed first order kinetic behavior. The fragmentation pathway of azelastine hydrochloride with mass spectrometry was taken as example; to correlate the thermal decomposition with the resulted MS-EI. The melting point and purity were determined using DSC and Van’t Hoff equation for the studied drugs. The results were in agreement with the recommended pharmacopoeias.