Journal : Acta Chromatographica
Article : Stability-indicating HPTLC method for quantitation of quetiapine fumarate in the pharmaceutical dosage form

Authors :
Turło, J.
Medical University of Warsaw Department of Drug Technology 1 Banacha Street 02-097 Warsaw Poland Medical University of Warsaw Faculty of Pharmacy 1 Banacha Street 02-097 Warsaw Poland, jadwiga.turlo@wum.edu.p,
Komsta, Ł.
Medical University of Lublin Chair and Department of Medicinal Chemistry, Faculty of Pharmacy Jaczewskiego 4 20-090 Lublin Poland Medical University of Lublin Chair and Department of Pharmaceutical Botany, Faculty of Pharmacy Chodźki 1 20-093 Lublin Pola, lukasz.komsta@am.lublin.pl,
Vasta, J. D.
Lafayette College Department of Chemistry Easton PA 18042-1782 USA Lafayette College Department of Biology Easton PA 18042-1782 USA, shermaj@mail.lafayette.edu,
Sajewicz, M.
Silesian University Institute of Chemistry 9 Szkolna Street 40-006 Katowice Poland, kowalska@us.edu.pl,
Raju, Ch. B. V. N.
Aurobindo Pharma Limited Srikakulam Dist. Pydibhimavaram 532 409 India Andhra University Department of Inorganic and Analytical Chemistry Visakhapatnam 530 003 India, chbvn_5@yahoo.co.in,
Shende, P.
NMIMS University School of Pharmacy and Technology Management V.L. Mehta Road, Vile Parle (W) Mumbai 400056 India, shendepravin94@yahoo.co.in,
Dhaneshwar, S. R.
Bharati Vidyapeeth University, Poona College of Pharmacy Department of Pharmaceutical Chemistry Pune 411038 India, sunil.dhaneshwar@gmail.com,
Abstract : A sensitive, selective, precise, and stability-indicating HPTLC method for quantitative analysis of quetiapine fumarate both as the bulk drug and in formulations has been established and validated. The stationary phase was silica gel and the mobile phase toluene-methanol 8:2 (v/v). This system gave compact bands for quetiapine fumarate ( R F 0.37 š 0.02). Densitometric analysis of quetiapine fumarate was performed in absorbance mode at 254 nm. There was no chromatographic interference from tablet excipients. Quetiapine fumarate was subjected to acid and alkaline hydrolysis, oxidation, and photodegradation. The drug is susceptible to all these treatments. The degradation products were well resolved from the pure drug with substantially different R F values. The method was validated for linearity, precision, accuracy, selectivity, and specificity in accordance with ICH guidelines. Because the method can effectively separate the drug from its degradation products, it can be used as a stability indicating method.

Keywords : quetiapine fumarate, HPTLC, validation, stability-indicating method,
Publishing house : University of Silesia in Katowice
Publication date : 2009
Number : Vol. 21, no. 1
Page : 83 – 93

Bibliography
: 1 http://www.seroquel.com/index.aspx.html (accessed on October 03, 2006)
2 http://www.rxlist.com/seroquel-drug.htm (Accessed on October 13, 2006)
3 International Conference on Harmonization (ICH), Stability Testing of New Drug Substances and Products, Q1A (R2), IFPMA, Geneva, Switzerland, 2003
4 M. Laura, G. Maria, B. Claudio, B. Giancarlo, and A.R. Maria, J. Anal. Bioanal. Chem., 388 , 235 (2007)
5 K.M. Vijaya and P.R. Muley, Indian Drugs, 41 , 272 (2004)
6 M.A. Saracino, L. Mercolini, G. Flotta, L.J. Albers, R. Merli, and M.A. Raggi, J. Chromatogr. B, 843 , 227 (2006)
7 R. Mandrioli, S. Fanali, A. Ferranti, and M.A. Raggi, J. Pharm. Biomed. Anal., 30 , 969 (2002)
8 B. Barrett, M. Holcapek, J. Huclov, V. Borek-Dohalsky, P. Fejt, B. Nemec, and I. Jelınek, J. Pharm. Biomed. Anal., 44 , 498 (2007)
9 ICH Guidance on Analytical Method Validation. In: Proc. Int. Convention on Quality for the Pharmaceutical Industry, Toronto, Canada, September, 2002.
DOI :
Qute : Turło, J. ,Komsta, Ł. ,Vasta, J. D. ,Sajewicz, M. ,Raju, Ch. B. V. N. ,Shende, P. ,Dhaneshwar, S. R. ,Dhaneshwar, S. R. , Stability-indicating HPTLC method for quantitation of quetiapine fumarate in the pharmaceutical dosage form. Acta Chromatographica Vol. 21, no. 1/2009
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