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Ion Chromatographic Method for Determination of Chloroacetic Acid in Isoproterenol Hydrochloride Drug Substance: A Genotoxic Impurity in Trace Levels
Corresponding Author(s) : M. Nageswara Rao
Asian Journal of Chemistry,
Vol. 29 No. 10 (2017): Vol 29 Issue 10
Abstract
A simple efficient ion chromatographic method developed, optimized and validated for the estimation of trace levels of chloroacetic acid was developed. The validation of this method was realized through specificity, linearity, limit of detection, limit of quantification, precision and accuracy parameters. The analysis was carried out on METROSEP ASUPP 5 (6.1006.530), 250 mm long, 4.0 mm and maintained at ambient conditions.
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References
Heidelberg, Beilstein Handbook of Organic Chemistry, Springer, vol. 1, edn 4, pp. 194-197 (1985).
G. Koenig, E. Lohmer, N. Rupprich, M. Lison and A. Gnass, Chloroacetic Acids, Ullmann’s Encyclopedia of Industrial Chemistry, vol. 2, pp.473-490 (2012).
S. Sweetman, Martindale-The Complete Drug Reference, Pharmaceutical Press, London, edn 34 (2004).
R.S.M. Ryan, D.K. Mehta and H.V. Hogerzeil, WHO Model Formulary 2004. World Health Organization (2004).
C. Kaiser, D.F. Colella, M.S. Schwartz, E. Garvey and J.R. Wardell, J. Med. Chem., 17, 49 (1974); https://doi.org/10.1021/jm00247a011.
J.M. Sendra and V. Todo, J. Inst. Brew., 96, 85 (1990); https://doi.org/10.1002/j.2050-0416.1990.tb01019.x.
Q. Feng and M. Shifen, Microchem. J., 63, 317 (1999); https://doi.org/10.1006/mchj.1999.1759.
M.G. Pervova, V.E. Kirichenko and K.I. Pashkevich, J. Anal. Chem., 57, 326 (2002); https://doi.org/10.1023/A:1014902431520.
ICH, Q2A Text on Validation of Analytical Procedure, International Conference on Harmonization, October (1994).
ICH, Q3B Validation of Analytical Procedure–Methodology, International Conference on Harmonization, November (1996).