Quantitative determination of residual 2-(2-chloroethoxy) ethanol (CEE) in quetiapine fumarate by gas chromatogaraphy
ABSTRACT
A simple and specific gas chromatographic method developed and validated for the determination of 2-(2-chloroethoxy) ethanol in Quetiapine Fumarate. The method is carried out with a flame ionization detector and DB-FFAP capillary column. The linearity was established over a range of 40-150 µg ml-1 and correlation coefficient is more than 0.999.
A simple and specific gas chromatographic method developed and validated for the determination of 2-(2-chloroethoxy) ethanol in Quetiapine Fumarate. The method is carried out with a flame ionization detector and DB-FFAP capillary column. The linearity was established over a range of 40-150 µg ml-1 and correlation coefficient is more than 0.999.
Cite this paper
nullTiwari, P. , Yadav, R. , Sathe, P. and Gangrade, D. (2010) Quantitative determination of residual 2-(2-chloroethoxy) ethanol (CEE) in quetiapine fumarate by gas chromatogaraphy. Advances in Bioscience and Biotechnology, 1, 367-371. doi: 10.4236/abb.2010.15049.
nullTiwari, P. , Yadav, R. , Sathe, P. and Gangrade, D. (2010) Quantitative determination of residual 2-(2-chloroethoxy) ethanol (CEE) in quetiapine fumarate by gas chromatogaraphy. Advances in Bioscience and Biotechnology, 1, 367-371. doi: 10.4236/abb.2010.15049.
References
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[1] Richelson, E. (1999) J. Clin. Psychiatry, 60(Suppl 10), 5. [2] Caley, C.F. and Rosenbaum, S. (1998) Formulary, 33, 105. [3] Proceedings of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Tripartite harmonised guideline Q3C Impurities: Residual Solvent’s, 1997. [4] The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use, ICH Topic Q3C (M) Maintenance of Note for guidance on Impurities: Residual solvents (CPMP/ICH/283/95), Permissible Daily Exposure (PDE) for Tetrahydrofuran and N-Methylpyrrolidone?. [5] Proceedings of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Tripartite harmonised guideline Q3A (R) Impurities in new drug substances?, 2002. [6] Residual solvents (5.4), European Pharmacopoeia, Supplement 4.6., Directorate for the Quality of Medicines of the Council of Europe, Strasbourg, fourth ed., p. 3911, 2004.