Journal :   Asian Journal of Research in Chemistry

Volume No. :   4

Issue No. :  6

Year :  2011

Pages :   965-967

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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Validated Chromatographic Method for the Determination of Process Related Genotoxic Impurity in Lansoprazole



Address:   M. Yogeshwar Reddy1,3*, V. Ramesh2, Ch. Kista Reddy3, N. Venugopal1, G.Saravanana1, M.V. Suryanarayana1, B. Shyam Sunder 1, R.Surendranath Reddy1 and G. Raju2
1Matrix Laboratories Ltd., R&D Centre, Jinnaram, Medak, 502325, India.
2National Centre for Mass Spectrometry, Indian Institute of Chemical Technology, Hyderabad, India.
3Department of Chemistry, P.G. College of Science, Saifabad, Hyderabad, India.
*Corresponding Author
DOI No:

ABSTRACT:
An LC-MS method for the simultaneous determination of process related impurity of 2-Chloromethyl-3-methyl-4-(2, 2, 2-trifluoroethoxy) pyridine Hydrochloride (CMTP, 1) and RP-LC method for the routine determination of 1 in Lansoprazole (2) was presented. In LC-MS, Hypersil BDS C-18 (150 X 4.6 mm, 5 µm) column was used with mobile phase containing buffer (0.01 M ammonium acetate), acetonitrile, and methanol in 50:45:5 v/v ratios. The flow rate was 0.8 mL min-1 and elution was monitored at 205 nm. LC analysis of 1 was done on Synergi polar RP-80A (250 X 4.6 mm, 4 µm) column using mobile phase containing buffer (0.1% triethyl amine) and acetonitrile in 65:35 v/v ratio. The flow rate was 0.8 mL min-1 and elution was monitored at 205 nm. Both methods were validated as per International Conference on Harmonization (ICH) guidelines. LC-MS is able to quantitate up to 0.9 ppm, whereas with RP-LC up to 30 ppm of 1 could be quantitated.
KEYWORDS:
Lansoprazole, Column liquid chromatography, Liquid chromatography-Mass spectrometry.
Cite:
M. Yogeshwar Reddy, V. Ramesh, Ch. Kista Reddy, N. Venugopal, G.Saravanana, M.V. Suryanarayana, B. Shyam Sunder, R.Surendranath Reddy, G. Raju. Validated Chromatographic Method for the Determination of Process Related Genotoxic Impurity in Lansoprazole. Asian J. Research Chem. 4(6): June, 2011; Page 965-967.
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