Journal : Acta Chromatographica
Article : Application of a stability-indicating HPTLC method for quantitative analysis of amtolmetin guacil in a pharmaceutical dosage form

Authors :
Dejaegher, B.
Vrije Universiteit Brussel — VUB Analytical Chemistry and Pharmaceutical Technology (FABI), Pharmaceutical Institute Laarbeeklaan 103 1090 Brussels Belgium,
Vander Heyden, Y.
Vrije Universiteit Brussel — VUB Analytical Chemistry and Pharmaceutical Technology (FABI), Pharmaceutical Institute Laarbeeklaan 103 1090 Brussels Belgium, yvanvdh@vub.ac.be,
Durón, R. R.
Universidad Autónoma de Nuevo León Departamento de Química Analítica, Facultad de Medicina P.O. Box 2316 Sucursal Tecnológico 64841 Monterrey Nuevo León México,
Almaguer, L. C.
Universidad Autónoma de Nuevo León Departamento de Química Analítica, Facultad de Medicina P.O. Box 2316 Sucursal Tecnológico 64841 Monterrey Nuevo León México,
Garza-Juárez, A.
Universidad Autónoma de Nuevo León Departamento de Química Analítica, Facultad de Medicina P.O. Box 2316 Sucursal Tecnológico 64841 Monterrey Nuevo León México,
Salazar Cavazos, M. L.
Universidad Autónoma de Nuevo León Departamento de Química Analítica, Facultad de Medicina P.O. Box 2316 Sucursal Tecnológico 64841 Monterrey Nuevo León México,
Waksman de Torres, N.
Universidad Autónoma de Nuevo León Departamento de Química Analítica, Facultad de Medicina P.O. Box 2316 Sucursal Tecnológico 64841 Monterrey Nuevo León México, nwaksman@fm.uanl.mx,
Garza-Juárez, A.
UANL, México Department of Analytical Chemistry, Facultad de Medicina Maderoy Aguirre Pequeño Col. Mitras Centro C.P. 64460 Mty, N.L. México,
Waksman de Torres, N.
UANL, México Department of Analytical Chemistry, Facultad de Medicina Maderoy Aguirre Pequeño Col. Mitras Centro C.P. 64460 Mty, N.L. México,
Salazar Cavazos, M. L.
UANL, México Department of Analytical Chemistry, Facultad de Medicina Maderoy Aguirre Pequeño Col. Mitras Centro C.P. 64460 Mty, N.L. México, masalaz52@yahoo.com,
Durón, R. R.
UANL, México Department of Analytical Chemistry, Facultad de Medicina Maderoy Aguirre Pequeño Col. Mitras Centro C.P. 64460 Mty, N.L. México,
Briciu, R. D.
Babeş-Bolyai University Faculty of Chemistry and Chemical Engineering Arany Janos Str. No 11 RO-400028 Cluj Napoca Romania,
Kot-Wasik, A.
Gdańsk University of Technology Chemical Faculty Narutowicza Str. No 11/12 80-952 Gdańsk Poland,
Namieśnik, J.
Gdańsk University of Technology Chemical Faculty Narutowicza Str. No 11/12 80-952 Gdańsk Poland,
Sârbu, C.
Babeş-Bolyai University Faculty of Chemistry and Chemical Engineering Arany Janos Str. No 11 RO-400028 Cluj Napoca Romania, costelsrb@yahoo.co.uk,
Sławik, T.
Medical University of Lublin Department of Medicinal Chemistry, Pharmaceutical Faculty Jaczewskiego 4 20-090 Lublin Poland,
Skibiński, R.
Medical University of Lublin Department of Medicinal Chemistry, Pharmaceutical Faculty Jaczewskiego 4 20-090 Lublin Poland, robert.skibinski@am.lublin.pl,
Paw, B.
Medical University of Lublin Department of Medicinal Chemistry, Pharmaceutical Faculty Jaczewskiego 4 20-090 Lublin Poland,
Działo, G.
Medical University of Lublin Department of Medicinal Chemistry, Pharmaceutical Faculty Jaczewskiego 4 20-090 Lublin Poland,
Sajewicz, M.
Silesian University Institute of Chemistry 9 Szkolna Street 40-006 Katowice Poland,
Matlengiewicz, M.
Silesian University Institute of Chemistry 9 Szkolna Street 40-006 Katowice Poland,
Kronenbach, D.
Silesian University Institute of Chemistry 9 Szkolna Street 40-006 Katowice Poland,
Gontarska, M.
Silesian University Institute of Chemistry 9 Szkolna Street 40-006 Katowice Poland,
Kowalska, T.
Silesian University Institute of Chemistry 9 Szkolna Street 40-006 Katowice Poland, kowalska@us.edu.pl,
Ekiert, R. J.
Jagiellonian University Department of Inorganic and Analytical Chemistry, Collegium Medicum 9 Medyczna St 30-688 Kraków Poland,
Krzek, J.
Jagiellonian University Department of Inorganic and Analytical Chemistry, Collegium Medicum 9 Medyczna St 30-688 Kraków Poland, jankrzek@cm-uj.krakow.pl,
Czekaj, J. S.
Jagiellonian University Department of Inorganic and Analytical Chemistry, Collegium Medicum 9 Medyczna St 30-688 Kraków Poland,
Hubicka, U.
Jagiellonian University Department of Inorganic and Analytical Chemistry, Collegium Medicum 9 Medyczna St 30-688 Kraków Poland,
Azeem, A.
Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India,
Rizwan, M.
Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India,
Ahmad, F. J.
Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India,
Iqbal, Z.
Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India,
Khar, R. K.
Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India,
Aqil, M.
Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India,
Talegaonkar, S.
Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India, stalegaonkar@jamiahamdard.ac.in,
Bhusari, V. K.
Bharati Vidyapeeth University, Poona College of Pharmacy Department of Pharmaceutical Chemistry Pune Maharashtra India 411038,
Mahadik, M. V.
Bharati Vidyapeeth University, Poona College of Pharmacy Department of Pharmaceutical Chemistry Pune Maharashtra India 411038,
Dhaneshwar, S. R.
Bharati Vidyapeeth University, Poona College of Pharmacy Department of Pharmaceutical Chemistry Pune Maharashtra India 411038, sunil.dhaneshwar@gmail.com,
Abstract : A sensitive, selective, precise, and stability-indicating HPTLC method has been established for analysis of amtolmetin guacil both as the bulk drug and in a formulation. Aluminum foil-backed silica gel 60F 254 plates were used with toluene-ethyl acetate 4:6 ( υ/υ ) as mobile phase, and densitometric analysis was performed in absorbance mode at 320 nm. The method was validated for linearity, precision, accuracy, selectivity, and specificity in accordance with ICH guidelines. Amtolmetin guacil was subjected to acidic and alkaline hydrolysis, oxidation, dry heat treatment, and photo-degradation. The method was used to study the kinetics of degradation of amtolmetin guacil by acid and alkali.

Keywords : amtolmetin guacil, HPTLC, stability-indicating, validation,
Publishing house : University of Silesia in Katowice
Publication date : 2009
Number : Vol. 21, no. 2
Page : 299 – 317

Bibliography
: 1 S. Singh, M. Bakshi, Pharm. Tech. On-line, 24 , 1–14 (2000)
2 ICH, Stability Testing of New Drug Substances and Products Q1A (R2), International Conference on Harmonization, IFPMA, Geneva, 2003
3 ICH, Stability Testing: Photostability Testing of New Drug Substances and Products Q1B. In: Proc. Int. Conf. Harmonization, IFPMA, Geneva, 1996
4 N. Allinger, J. Am. Chem. Soc., 99 , 8127–8134 (1977)
5 U. Burkert and N.L. Allinger, In: Molecular Mechanics, Vol. 99, American Chemical Society, Washington, DC, 1982, pp. 8127–8134
6 E. Tubaro, L. Belogi, and C.M. Mezzadri, Arzneimittelforschung, 51 , 737–742 (2001)
7 R. Marcolongo, B. Frediani, G. Biasi, C. Minari, and C. Barreca, Clin. Drug Invest., 17 , 89–96 (1999)
8 P.G. Bianchi, F. Monitrone, M. Lazzaroni, G. Manzionna, and I. Caruso, J. Gastroenterol., Hepatol., 31 , 378–385 (1999)
9 D.V. Subba Rao, P. Radhakrishnanand, K.V. Surendranath, P. Raghuram, and V. Himabindu, Chromatographia, 68 , 567–577 (2008)
10 ICH, Q2 (R1) Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonization, Geneva, 2005
DOI :
Qute : Dejaegher, B. ,Vander Heyden, Y. ,Durón, R. R. ,Almaguer, L. C. ,Garza-Juárez, A. ,Salazar Cavazos, M. L. ,Waksman de Torres, N. ,Garza-Juárez, A. ,Waksman de Torres, N. ,Salazar Cavazos, M. L. ,Durón, R. R. ,Briciu, R. D. ,Kot-Wasik, A. ,Namieśnik, J. ,Sârbu, C. ,Sławik, T. ,Skibiński, R. ,Paw, B. ,Działo, G. ,Sajewicz, M. ,Matlengiewicz, M. ,Kronenbach, D. ,Gontarska, M. ,Kowalska, T. ,Ekiert, R. J. ,Krzek, J. ,Czekaj, J. S. ,Hubicka, U. ,Azeem, A. ,Rizwan, M. ,Ahmad, F. J. ,Iqbal, Z. ,Khar, R. K. ,Aqil, M. ,Talegaonkar, S. ,Bhusari, V. K. ,Mahadik, M. V. ,Dhaneshwar, S. R. ,Dhaneshwar, S. R. , Application of a stability-indicating HPTLC method for quantitative analysis of amtolmetin guacil in a pharmaceutical dosage form. Acta Chromatographica Vol. 21, no. 2/2009
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