Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
7632892 | Journal of Pharmaceutical and Biomedical Analysis | 2012 | 6 Pages |
Abstract
A sensitive and selective liquid chromatographic-tandem mass spectrometric (LC/MS/MS) method was developed and validated for the trace analysis (>1 ppm level) of 2-chloromethyl-3,4-dimethoxy pyridine hydrochloride a genotoxic impurity in pantoprazole sodium drug substances. LC/MS/MS analysis of 2-chloromethyl-3,4-dimethoxy pyridine hydrochloride was done on Hypersil BDS C18 (50 mm Ã 4.6 mm) 3 μm column and 10 mM ammonium acetate in 1000 mL of water was used as buffer. The mobile phase used was in the ratio of buffer-acetonitrile (79:21, v/v). The flow rate was 1.0 mL/min and elution was monitored at 210 nm. The method was validated as per International Conference on Harmonization (ICH) guidelines. LC/MS/MS is able to quantitate up to 0.3 ppm of 2-chloromethyl-3,4-dimethoxy pyridine hydrochloride.
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
N. Venugopal, A. Vijaya Bhaskar Reddy, K. Gangadhar Reddy, V. Madhavi, G. Madhavi,