Journal : Acta Chromatographica
Article : Stability-indicating high-performance thin-layer chromatographic method for analysis of terbinafine in pharmaceutical formulations

Authors :
Daszykowski, M.
Silesian University Department of Chemometrics, Institute of Chemistry 9 Szkolna Street 40-006 Katowice Poland,
Sajewicz, M.
Silesian University Department of General Chemistry and Chromatography 9 Szkolna Street 40-006 Katowice Poland,
Rzepa, J.
Silesian University Department of General Chemistry and Chromatography 9 Szkolna Street 40-006 Katowice Poland,
Hajnos, M.
Medical University of Lublin Department of Pharmacognosy 1 Chodźki Street 20-093 Lublin Poland,
Staszek, D.
Silesian University Department of General Chemistry and Chromatography 9 Szkolna Street 40-006 Katowice Poland,
Wojtal, Ł.
Silesian University Department of General Chemistry and Chromatography 9 Szkolna Street 40-006 Katowice Poland,
Kowalska, T.
Silesian University Department of General Chemistry and Chromatography 9 Szkolna Street 40-006 Katowice Poland,
Waksmundzka-Hajnos, M.
Medical University of Lublin Department of Inorganic Chemistry 6 Staszica Street 20-081 Lublin Poland,
Walczak, B.
Silesian University Department of Chemometrics, Institute of Chemistry 9 Szkolna Street 40-006 Katowice Poland, beata@us.edu.pl,
Skalicka-Woźniak, K.
Medical University of Lublin Department of Pharmacognosy with Medicinal Plant Laboratory 1 Chodzki Str. 20-093 Lublin Poland,
Markowski, W.
Medical University of Lublin Department of Physical Chemistry Staszica 6 20-081 Lublin Poland,
Świeboda, R.
Medical University of Lublin Department of Inorganic and Analytical Chemistry Staszica 6 20-081 Lublin Poland,
Głowniak, K.
Medical University of Lublin Department of Pharmacognosy with Medicinal Plant Laboratory 1 Chodzki Str. 20-093 Lublin Poland,
Sultana, N.
University of Karachi Research Institute of Pharmaceutical Sciences, Department of Pharmaceutical Chemistry, Faculty of Pharmacy Karachi 75270 Pakistan,
Arayne, M. S.
University of Karachi Department of Chemistry Karachi 75270 Pakistan,
Naveed, S.
University of Karachi Research Institute of Pharmaceutical Sciences, Department of Pharmaceutical Chemistry, Faculty of Pharmacy Karachi 75270 Pakistan,
Shamshad, H.
University of Karachi Research Institute of Pharmaceutical Sciences, Department of Pharmaceutical Chemistry, Faculty of Pharmacy Karachi 75270 Pakistan,
Li, X.
China Agricultural University Department of Applied Chemistry, College of Science Beijing 100193 China,
Xu, J.
China Agricultural University Department of Applied Chemistry, College of Science Beijing 100193 China,
Jiang, Y.
China Agricultural University Department of Applied Chemistry, College of Science Beijing 100193 China,
Chen, L.
China Agricultural University Department of Applied Chemistry, College of Science Beijing 100193 China,
Xu, Y.
China Agricultural University Department of Applied Chemistry, College of Science Beijing 100193 China,
Pan, C.
China Agricultural University Department of Applied Chemistry, College of Science Beijing 100193 China,
Sheikhloie, H.
slamic Azad University, Science and Research Branch Department of Chemistry, Faculty of Science Poonak-Hesarak, Tehran Iran,
Saber-Tehrani, M.
slamic Azad University, Science and Research Branch Department of Chemistry, Faculty of Science Poonak-Hesarak, Tehran Iran,
Abrumand-Azar, P.
slamic Azad University, Science and Research Branch Department of Chemistry, Faculty of Science Poonak-Hesarak, Tehran Iran,
Waqif-Husain, S.
slamic Azad University, Science and Research Branch Department of Chemistry, Faculty of Science Poonak-Hesarak, Tehran Iran,
Mincea, M.
West University of Timişoara Faculty of Chemistry-Biology-Geography, Department of Chemistry Pestalozzi Street, 16 Timişoara 300115 Romania,
Lupşa, I.
Institute of Public Health Timişoara Department of Food Hygiene V. Babeş 16-18 Timişoara 300226 Romania,
Talpoş, I.
West University of Timişoara Multidisciplinary Research Platform “Nicholas Georgescu-Roegen” Oituz 4 Timişoara Romania,
Ostafe, V.
West University of Timişoara Faculty of Chemistry-Biology-Geography, Department of Chemistry Pestalozzi Street, 16 Timişoara 300115 Romania, vostafe@cbg.uvt.ro,
Milenović, D. M.
Zdravlje-Actavis Company, R&D Analytical Department 16000 Leskovac Serbia, dmilenovic@actavis.rs,
Todorović, Z. B.
University of Niš Faculty of Technology 16000 Leskovac Serbia,
Rane, V. P.
Dr Babasaheb Ambedkar Marathwada University Department of Chemical Technology Aurangabad 431004 (MS) India,
Patil, K. R.
Dr Babasaheb Ambedkar Marathwada University Department of Chemical Technology Aurangabad 431004 (MS) India,
Sangshetti, J. N.
Wockhardt Research Centre Aurangabad 431210 (MS) India,
Yeole, R. D.
Wockhardt Research Centre Aurangabad 431210 (MS) India,
Shinde, D. B.
Dr Babasaheb Ambedkar Marathwada University Department of Chemical Technology Aurangabad 431004 (MS) India,
Ahmad, S.
Hamdard University Department of Pharmaceutics, Faculty of Pharmacy Hamdard Nagar New Delhi 110062 India,
Jain, G. K.
Hamdard University Department of Pharmaceutics, Faculty of Pharmacy Hamdard Nagar New Delhi 110062 India,
Faiyazuddin, M.
Hamdard University Department of Pharmaceutics, Faculty of Pharmacy Hamdard Nagar New Delhi 110062 India,
Iqbal, Z.
Hamdard University Department of Pharmaceutics, Faculty of Pharmacy Hamdard Nagar New Delhi 110062 India,
Talegaonkar, S.
Hamdard University Department of Pharmaceutics, Faculty of Pharmacy Hamdard Nagar New Delhi 110062 India,
Sultana, Y.
Hamdard University Department of Pharmaceutics, Faculty of Pharmacy Hamdard Nagar New Delhi 110062 India,
Ahmad , F. J.
Hamdard University Department of Pharmaceutics, Faculty of Pharmacy Hamdard Nagar New Delhi 110062 India,
Abstract : A new, simple, selective, precise, robust and stability-indicating high-performance thin-layer chromatographic (HPTLC) method has been established for analysis of terbinafine hydrochloride (TH) in the bulk drug and in pharmaceutical formulations. Separation was achieved on aluminium plates precoated with silica gel 60F 254 , with toluene-ethyl acetate-formic acid 4.5:5.5:0.1 ( v/v ) as mobile phase. Densitometric analysis was performed at 284 nm. Compact bands of TH were obtained at R F 0.31 ± 0.02. Linearity ( r 2 = 0.9985), limit of quantification (35 ng per band), recovery (97.6−101.6%), and precision (≤2.19) were satisfactory. The method was applicable for routine analysis and accelerated stability testing of TH in pharmaceutical drug-delivery systems. Because the method can effectively separate the drug from its degradation products, it can be used as a stability-indicating method.

Keywords : terbinafine, high-performance thin-layer chromatography, degradation, stability,
Publishing house : University of Silesia in Katowice
Publication date : 2009
Number : Vol. 21, no. 4
Page : 631 – 639

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DOI :
Qute : Daszykowski, M. ,Sajewicz, M. ,Rzepa, J. ,Hajnos, M. ,Staszek, D. ,Wojtal, Ł. ,Kowalska, T. ,Waksmundzka-Hajnos, M. ,Walczak, B. ,Skalicka-Woźniak, K. ,Markowski, W. ,Świeboda, R. ,Głowniak, K. ,Sultana, N. ,Arayne, M. S. ,Naveed, S. ,Shamshad, H. ,Li, X. ,Xu, J. ,Jiang, Y. ,Chen, L. ,Xu, Y. ,Pan, C. ,Sheikhloie, H. ,Saber-Tehrani, M. ,Abrumand-Azar, P. ,Waqif-Husain, S. ,Mincea, M. ,Lupşa, I. ,Talpoş, I. ,Ostafe, V. ,Milenović, D. M. ,Todorović, Z. B. ,Rane, V. P. ,Patil, K. R. ,Sangshetti, J. N. ,Yeole, R. D. ,Shinde, D. B. ,Ahmad, S. ,Jain, G. K. ,Faiyazuddin, M. ,Iqbal, Z. ,Talegaonkar, S. ,Sultana, Y. ,Ahmad , F. J. ,Ahmad , F. J. , Stability-indicating high-performance thin-layer chromatographic method for analysis of terbinafine in pharmaceutical formulations. Acta Chromatographica Vol. 21, no. 4/2009
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