PDF
Open Access
Detection, Isolation and Characterization of Principal Synthetic Route Indicative Impurity in Lansoprazole
K. S. V Srinivas
,1 K. Mukkanti,3 R. Buchi Reddy,2 and P. Srinivasulu31Analytical Development Laboratory, Inogent Laboratories Private Limited, No. 28A, IDA, Nacharam, Hyderabad-500 076, India
2Research & Development Laboratory, Inogent Laboratories Private Limited, No. 28A, IDA, Nacharam, Hyderabad-500 076, India
3Centre for Environment, JNT University, Kukatpally, Hyderabad-500 072, India
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
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.
