A validated densitometric method for analysis of aceclofenac and paracetamol as the bulk drugs and in combined tablet dosage forms

• Autorzy: Gandhi S. V. , Barhate N. S. , Patel B. R. , Panchal D. D. , Bothara K. G.
• Języki publikacji: EN

Abstrakty

EN

A simple, specific, accurate, and precise high-performance thin-layer chromatographic method for analysis of aceclofenac and paracetamol in combined tablet dosage forms is reported in this paper. The method uses aluminium plates coated with silica gel 60 F₂₅₄ as stationary phase and ethyl acetate-n-butanol-glacial acetic acid 7.5:2.5:0.005 (v/v) as mobile phase. Densitometric evaluation of the separated bands was performed at 270 nm. The two drugs were satisfactorily resolved with R_F values 0.29 š 0.019 and 0.74 š 0.025 for aceclofenac and paracetamol, respectively. The respective calibration plots were linear over the ranges 50-1000 and 200-1500 ng per band. Intra-day variation, as RSD (%), was 0.420 š 0.282 for aceclofenac and 0.354 š 0.212 for paracetamol. Interday variation, as RSD (%) š SE, was 0.57 š 0.41 for aceclofenac and 0.90 š 1.09 for paracetamol. The method, which was validated in accordance with ICH guidelines, can be used for analysis of ten or more formulations on a single plate and is a rapid and costeffective quality-control tool for routine simultaneous analysis of aceclofenac and paracetamol in combined dosage forms.

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2008
• Tom: Vol. 20, no. 2
• Strony: 175--182
• Opis fizyczny: Bibliogr. 19 poz., rys., tab.

Twórcy

autor

Gandhi S. V.

autor

Barhate N. S.

autor

Patel B. R.

autor

Panchal D. D.

autor

Bothara K. G.

• Department of Pharmaceutical Analysis, A.I.S.S.M.S. College of Pharmacy, Kennedy Road, Pune-411 001, India,

Bibliografia

• [1] J.E.F. Reynolds and B.A. Prasad, Martindale – The Extra Pharmacopoeia, 30th edn, The Pharmaceutical Press, London, 1993
• [2] European Pharmacopoeia, 4th edn, Council of Europe, Strasbourg cedex, France, 2002
• [3] N.M. EI Kousy, J. Pharm. Biomed. Anal., 20, 184 (1999)
• [4] N.M. EI Kousy, N.H. Zawilla, A.A. Mohammad, and S.M. El-Moghazy, J. Pharm. Biomed. Anal., 27, 243 (2002)
• [5] S. Shanmugam, A.K. Cendil, J. Vetrichelvan, R. Manavalan, D. Venkappayya, and V.P. Pandey, Indian Drugs, 42, 106 (2005)
• [6] Y.S. Saharty, M. Refaat, and S.Z. el-Khateeb, Drug Dev. Ind. Pharm., 28, 571 (2002)
• [7] British Pharmacopoeia, Vol. 1, International edn, HMSO, London, 1993
• [8] Indian Pharmacopoeia, Vol. 2, 4th edn, Government of India, Ministry of Health and Family Welfare, 1996
• [9] E. Dinc, C. Yucesoy, and F. Onur, J. Pharm. Biomed. Anal., 28, 1092 (2002)
• [10] S. Ravisankar, M. Vasudevan, S. Mathew, and B. Suresh, Indian Drugs, 35, 306 (1998)
• [11] P. Nagaraja, K.C. Murthy, and K.S. Rangapa, J. Pharm. Biomed. Anal., 17, 501 (1998)
• [12] E. Dinc, J. Pharm. Biomed. Anal., 21, 723 (1999)
• [13] N. Erk and Y. Ozkan, J. Pharm. Biomed. Anal., 24, 469 (2001)
• [14] S.S. Zarapkar, U.P. Halkar, and N.P. Bhandari, Indian Drugs, 36, 710 (1999)
• [15] K.R.P. Shenoy, K.S. Krishnamurthi, and K.S. Sumatheendra, Indian Drugs, 37, 486 (2000)
• [16] D. Patil and B. Raman, Indian Drugs, 38, 36 (2001)
• [17] J.O. Maryadele and A. Smith, The Merck Index 12th edn, Merck Research Laboratories, NJ, USA, 1996
• [18] A.D. Nikam, S.S. Pawar, and S.V. Gandhi, Asian J. Chem., 19, 5075 (2007)
• [19] ICH Harmonised Tripartite Guideline, Q2 (R1), Validation of Analytical Procedures: Text and Methodology, November, 2005.