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

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

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 di...

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Main Authors: K. S. V Srinivas, K. Mukkanti, R. Buchi Reddy, P. Srinivasulu
Format: Article
Language:English
Published: Hindawi Limited 2010-01-01
Series:E-Journal of Chemistry
Online Access:http://dx.doi.org/10.1155/2010/304315
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spelling doaj-74ed256d51e2461aa702e2c79600f2902020-11-24T22:12:35ZengHindawi LimitedE-Journal of Chemistry0973-49452090-98102010-01-017384484810.1155/2010/304315Detection, Isolation and Characterization of Principal Synthetic Route Indicative Impurity in LansoprazoleK. S. V Srinivas0K. Mukkanti1R. Buchi Reddy2P. Srinivasulu3Analytical Development Laboratory, Inogent Laboratories Private Limited, No. 28A, IDA, Nacharam, Hyderabad-500 076, IndiaCentre for Environment, JNT University, Kukatpally, Hyderabad-500 072, IndiaResearch & Development Laboratory, Inogent Laboratories Private Limited, No. 28A, IDA, Nacharam, Hyderabad-500 076, IndiaCentre for Environment, JNT University, Kukatpally, Hyderabad-500 072, IndiaAn 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.http://dx.doi.org/10.1155/2010/304315
collection DOAJ
language English
format Article
sources DOAJ
author K. S. V Srinivas
K. Mukkanti
R. Buchi Reddy
P. Srinivasulu
spellingShingle K. S. V Srinivas
K. Mukkanti
R. Buchi Reddy
P. Srinivasulu
Detection, Isolation and Characterization of Principal Synthetic Route Indicative Impurity in Lansoprazole
E-Journal of Chemistry
author_facet K. S. V Srinivas
K. Mukkanti
R. Buchi Reddy
P. Srinivasulu
author_sort K. S. V Srinivas
title Detection, Isolation and Characterization of Principal Synthetic Route Indicative Impurity in Lansoprazole
title_short Detection, Isolation and Characterization of Principal Synthetic Route Indicative Impurity in Lansoprazole
title_full Detection, Isolation and Characterization of Principal Synthetic Route Indicative Impurity in Lansoprazole
title_fullStr Detection, Isolation and Characterization of Principal Synthetic Route Indicative Impurity in Lansoprazole
title_full_unstemmed Detection, Isolation and Characterization of Principal Synthetic Route Indicative Impurity in Lansoprazole
title_sort detection, isolation and characterization of principal synthetic route indicative impurity in lansoprazole
publisher Hindawi Limited
series E-Journal of Chemistry
issn 0973-4945
2090-9810
publishDate 2010-01-01
description 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.
url http://dx.doi.org/10.1155/2010/304315
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AT kmukkanti detectionisolationandcharacterizationofprincipalsyntheticrouteindicativeimpurityinlansoprazole
AT rbuchireddy detectionisolationandcharacterizationofprincipalsyntheticrouteindicativeimpurityinlansoprazole
AT psrinivasulu detectionisolationandcharacterizationofprincipalsyntheticrouteindicativeimpurityinlansoprazole
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