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Stability-indicating high-performance thin-layer chromatographic method for analysis of terbinafine in pharmaceutical formulations

Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
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.
Rocznik
Strony
631--639
Opis fizyczny
Bibliogr. 9 poz., rys., tab.
Twórcy
autor
  • Hamdard University Department of Pharmaceutics, Faculty of Pharmacy Hamdard Nagar New Delhi 110062 India
autor
  • Hamdard University Department of Pharmaceutics, Faculty of Pharmacy Hamdard Nagar New Delhi 110062 India
  • Hamdard University Department of Pharmaceutics, Faculty of Pharmacy Hamdard Nagar New Delhi 110062 India
autor
  • Hamdard University Department of Pharmaceutics, Faculty of Pharmacy Hamdard Nagar New Delhi 110062 India
  • Hamdard University Department of Pharmaceutics, Faculty of Pharmacy Hamdard Nagar New Delhi 110062 India
autor
  • Hamdard University Department of Pharmaceutics, Faculty of Pharmacy Hamdard Nagar New Delhi 110062 India
autor
  • Hamdard University Department of Pharmaceutics, Faculty of Pharmacy Hamdard Nagar New Delhi 110062 India
Bibliografia
  • [1] P. Nussbaumer, I. Leitner, K. Mraz, and A. Stutz, J. Med. Chem., 38 , 1831, (1995)
  • [2] V.M. Gokhale and V.M. Kulkarni, Bioorg. Med. Chem., 8 , 2487 (2000)
  • [3] Y.S. El-Saharty, N.Y. Hassan, and F.H. Metwally, J. Pharm. Biomed. Anal., 28 , 569 (2002)
  • [4] S.G. Cardoso and E.E.S. Schapoval, JAOCS, 82 , 830 (1999)
  • [5] S.G. Cardoso and E.E.S. Schapoval, J. Pharm. Biomed. Anal., 19 , 809 (1999)
  • [6] S.G. Cardoso and E.E.S. Schapoval, Int. J. Pharm., 203 , 109 (2000)
  • [7] L. Matysova, P. Solich, P. Marek, L. Havlikova, L. Novakova, and J. Sicha, Talanta, 68 , 713 (2006)
  • [8] N. Jain, G.K. Jain, F.J. Ahmad, and R.K. Khar, Anal. Chim. Acta, 599 , 302 (2007)
  • [9] S.K. Motwani, F.J. Ahmad, R.K. Khar, S. Chopra, K. Kohli, and S. Talegaonkar, Anal. Chim. Acta, 582 , 75 (2007)
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-13545f43-c409-4fab-a3c0-a17eab335f55
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