Table of Contents Author Guidelines Submit a Manuscript
The Scientific World Journal
Volume 2013 (2013), Article ID 564962, 7 pages
http://dx.doi.org/10.1155/2013/564962
Research Article

Application of HPLC with ELSD Detection for the Assessment of Azelaic Acid Impurities in Liposomal Formulation

1Department of Industrial Pharmacy, Wroclaw Medical University, Borowska Street 211A, 50-556 Wroclaw, Poland
2Research and Development Center NOVASOME, Olsztyńska Street 5, 51-423 Wroclaw, Poland
3Department of Physical Chemistry, Wroclaw Medical University, Borowska Street 211A, 50-556 Wroclaw, Poland

Received 30 July 2013; Accepted 11 September 2013

Academic Editors: A. Concheiro and Y. Fiamegos

Copyright © 2013 Stanislaw Han et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

In the course of research and development of a new pharmaceutical formulation of azelaic acid in the liposomal form, we developed a rapid and accurate method for the detection of impurities using high-performance liquid chromatography. A chromatographic column from Merck (Purospher Star RP C18, 250–4 mm (5 μm) was used in the assay, and the mobile phase gradient consisted of three phases: A—methanol : water (5 : 95) + 1.5% (v/v) acetic acid; B—water : methanol (5 : 95) + 1.5% (v/v) acetic acid; and C—chloroform. Detection of the impurities and the active substance was performed by an evaporative light-scattering detector. The method was validated for selectivity, system precision, method precision, limit of detection, and response rates. The proposed method can be used to detect impurities in the liposomal formulation of azelaic acid. The method enables separation of azelaic acid from the identified and unidentified impurities and from the excipients used in the drug form.