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

• Autorzy: Bhusari V. K. , Mahadik M. V. , Dhaneshwar S. R.
• 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.

Słowa kluczowe

EN

amtolmetin guacil; HPTLC; stability-indicating; validation

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2009
• Tom: Vol. 21, no. 2
• Strony: 299--317
• Opis fizyczny: Bibliogr. 10 poz., rys., tab.

Twórcy

autor

Bhusari V. K.

• Bharati Vidyapeeth University, Poona College of Pharmacy Department of Pharmaceutical Chemistry Pune Maharashtra India 411038

autor

Mahadik M. V.

• Bharati Vidyapeeth University, Poona College of Pharmacy Department of Pharmaceutical Chemistry Pune Maharashtra India 411038

autor

Dhaneshwar S. R.

• Bharati Vidyapeeth University, Poona College of Pharmacy Department of Pharmaceutical Chemistry Pune Maharashtra India 411038

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