Journal of Chemistry

Journal of Chemistry / 2010 / Article

Open Access

Volume 7 |Article ID 304315 | 5 pages | https://doi.org/10.1155/2010/304315

Detection, Isolation and Characterization of Principal Synthetic Route Indicative Impurity in Lansoprazole

Received01 Apr 2009
Accepted01 Jun 2009

Abstract

An unknown impurity in lansoprazole (2-[[[3-methyl-4-(2, 2, 2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole) was detected by HPLC and was identified as des-(trifluoroethoxy) lansoprazole, an principal synthetic route indicative impurity of lansoprazole. Lansoprazole was subjected to different ICH prescribed stress conditions like hydrolysis, oxidation, photolysis and thermal degradation conditions to enrich the impurity. The impurity was enriched by using acid catalytic degradation, isolated by using preparative HPLC and characterized (FTIR, MS and NMR). Limit of Detection (LOD) and Limit of Quantification (LOQ) are found to be 0.014% and 0.035% respectively.

Copyright © 2010 Hindawi Publishing Corporation. 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.

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