Skip to Content
MDPIMDPI
Sci. Pharm.Scientia Pharmaceutica
PDF
  • Scientia Pharmaceutica is published by MDPI from Volume 84 Issue 3 (2016). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Austrian Pharmaceutical Society (Österreichische Pharmazeutische Gesellschaft, ÖPhG).
  • Article
  • Open Access

4 July 2009

Isolation and Characterization of a Trace Level Unknown Impurity of Salmeterol by Chromatographic and Spectroscopic Methods

,
,
,
and
1
Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500 072, India
2
Analytical Research, Discovery Research, Dr. Reddy’s Laboratories Ltd., Miyapur, Hyderabad-500 049, India
3
Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500 072, India
4
Department of Chemistry, Sri Venkateswara University, Tirupati-517 502, India
Sci. Pharm.2009, 77(3), 579-588;https://doi.org/10.3797/scipharm.0906-01
Version Notes
Order Reprints

Abstract

During the process development of Salmeterol, an unknown impurity was detected at 2.08 Relative Retention Time (RRT) at a level of 0.11% by a gradient Reverse Phase-High Performance Liquid Chromatography (RP-HPLC). The impurity was isolated from the salmeterol drug substance using preparative HPLC. The separation was achieved with an Inertsil C8 column, using acetonitrile–trifluroacetic acid buffer pH 2.7 as mobile phase. The isolated impurity was characterized by NMR and MS techniques. The impurity has been characterized as 4-(2-{[6-(4-cyclohexylbutoxy)hexyl]amino}-1-hydroxyethyl)- 2-(hydroxymethyl)phenol. The synthesis of the impurity and its formation was also discussed.

Article Metrics

Citations

Article Access Statistics

Journal Statistics
Multiple requests from the same IP address are counted as one view.
Preparation and Biological Evaluation of a [55Co]-2-Acetylpyridine Thiosemicarbazone
Previous
Comparative Study on Inhibitory Activity of Zerumbone and Zerumbone 2,3-Epoxide on NF-κB Activation and NO Production
Next