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Sci. Pharm. 2009, 77(3), 579-588; doi:10.3797/scipharm.0906-01

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

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
*
Author to whom correspondence should be addressed.
Received: 1 June 2009 / Accepted: 2 July 2009 / Published: 4 July 2009
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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.
Keywords: Salmeterol Impurity; Preparative HPLC; Spectroscopy; Isolation; Identification and Characterization Salmeterol Impurity; Preparative HPLC; Spectroscopy; Isolation; Identification and Characterization
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. (CC BY 4.0).

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MDPI and ACS Style

VENKATASUBBAIAH, B.; PRAKASH, L.R.; DEV, R.V.; VARAPRASAD, V.; SUBRAMANYAM REDDY, K. Isolation and Characterization of a Trace Level Unknown Impurity of Salmeterol by Chromatographic and Spectroscopic Methods. Sci. Pharm. 2009, 77, 579-588.

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