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A validated CE method for determining dimethylsulfate a carcinogen and chloroacetyl chloride a potential genotoxin at trace levels in drug substances.
- Source :
-
Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2012 Jan 25; Vol. 58, pp. 27-33. Date of Electronic Publication: 2011 Oct 01. - Publication Year :
- 2012
-
Abstract
- A simple and rapid capillary zone electrophoretic method was developed for determining dimethyl sulfate a possible human carcinogen and mutagen and chloroacetyl chloride a potential genotoxic agent at trace levels in pharmaceutical drug substances by indirect photometric detection. A systematic screening of various anionic probes was performed to obtain the best separation conditions and sensitivity. High sensitivities with low quantification and detection levels were achieved for dimethylsulfate and chloroacetyl chloride using a background electrolyte (BGE) containing 5 mM pyridine dicarboxylic acid as the probe ion. The method is specific, precise and accurate for the two genotoxins. The optimized method was validated for specificity, precision, linearity, accuracy and stability in solution. Calibration curves were linear (R>0.999) for both dimethylsulfate and chloroacetyl chloride in the range LOQ - 300% of nominal concentrations. The CE method was effectively implemented for estimating dimethylsulfate and chloroacetyl chloride in two different active pharmaceutical ingredients (APIs).<br /> (Copyright © 2011 Elsevier B.V. All rights reserved.)
- Subjects :
- Acetates chemistry
Calibration
Carcinogens chemistry
Electrolytes chemistry
Mutagens chemistry
Pharmaceutical Preparations chemistry
Sensitivity and Specificity
Sulfuric Acid Esters chemistry
Acetates analysis
Carcinogens analysis
Electrophoresis, Capillary methods
Mutagens analysis
Pharmaceutical Preparations analysis
Sulfuric Acid Esters analysis
Subjects
Details
- Language :
- English
- ISSN :
- 1873-264X
- Volume :
- 58
- Database :
- MEDLINE
- Journal :
- Journal of pharmaceutical and biomedical analysis
- Publication Type :
- Academic Journal
- Accession number :
- 22014653
- Full Text :
- https://doi.org/10.1016/j.jpba.2011.09.019