Quantitative determination of the iron chelating agent Deferaserux and one of its process-related substance by using high performance liquid chromatography
Abstract
Deferasirox is an iron-chelating agent indicated in the treatment of chronic iron overload. This work aims to develop a new validated sensitive RP-HPLC coupled with a UV detector for the determination of Deferasirox and one of the unstudied impurities. The separation was achieved on the Kromosil C8 column (length of 250mm, internal diameter of 4.0 mm, and 5-μm particle size) at a temperature of 25℃. Phosphate Buffer and acetonitrile were used as a mobile phase by isocratic mode at a 0.8 mL/min flow rate. A wavelength of 254nm was selected to perform detection using a photodiode array detector. The method met the requirement of the International Conference on Harmonisation requirement for validation for the Registration of Pharmaceuticals for Human Use (ICH). The limit of detection (LOD) for Deferasirox was found to be 5.59 ng/mL and 8.35 ng/mL for the impurity DRS-1. The developed method was then tested by analyzing some samples of active pharmaceutical ingredients. The Impurity DRS-1 exceeded the impurities' acceptable limits (0.1%) in one of these samples.
Downloads
Published
How to Cite
Issue
Section
License
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
The authors retain the copyright and grant the right to publish in the magazine for the first time with the transfer of the commercial right to Tishreen University Journal for Research and Scientific Studies - Health Sciences Series
Under a CC BY- NC-SA 04 license that allows others to share the work with of the work's authorship and initial publication in this journal. Authors can use a copy of their articles in their scientific activity, and on their scientific websites, provided that the place of publication is indicted in Tishreen University Journal for Research and Scientific Studies - Health Sciences Series . The Readers have the right to send, print and subscribe to the initial version of the article, and the title of Tishreen University Journal for Research and Scientific Studies - Health Sciences Series Publisher
journal uses a CC BY-NC-SA license which mean
You are free to:
- Share — copy and redistribute the material in any medium or format
- Adapt — remix, transform, and build upon the material
- The licensor cannot revoke these freedoms as long as you follow the license terms.
- Attribution — You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
- NonCommercial — You may not use the material for commercial purposes.
- ShareAlike — If you remix, transform, or build upon the material, you must distribute your contributions under the same license as the original.
- No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.