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2009 | Vol. 21, no. 2 | 299--317
Tytuł artykułu

Application of a stability-indicating HPTLC method for quantitative analysis of amtolmetin guacil in a pharmaceutical dosage form

Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
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.
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Wydawca

Rocznik
Strony
299--317
Opis fizyczny
Bibliogr. 10 poz., rys., tab.
Twórcy
  • Bharati Vidyapeeth University, Poona College of Pharmacy Department of Pharmaceutical Chemistry Pune Maharashtra India 411038
  • Bharati Vidyapeeth University, Poona College of Pharmacy Department of Pharmaceutical Chemistry Pune Maharashtra India 411038
  • Bharati Vidyapeeth University, Poona College of Pharmacy Department of Pharmaceutical Chemistry Pune Maharashtra India 411038, sunil.dhaneshwar@gmail.com
Bibliografia
  • [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
Typ dokumentu
Bibliografia
Identyfikatory
Identyfikator YADDA
bwmeta1.element.baztech-414fe573-349b-462d-ba80-214f0c5dc548
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