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An isocratic RP-HPLC method has been developed and validated for simultaneous analysis of ambroxol hydrochloride (AMB) with cetirizine hydrochloride (CTZ) and of ambroxol hydrochloride (AMB) with levo -cetirizine dihydrochloride (LCTZ) in combined solid dosage forms. Formulations containing AMB with CTZ (tablets) and AMB with LCTZ (capsules) are used as antihistaminic H 1 blockers. Chromatography was performed on a 250 mm × 4.6 mm, 5-µm particle size, C 18 (ODS) column with a 45:30:30 ( v/v ) mixture of 30 mM aqueous ammonium sulphate (pH 5.5), acetonitrile, and methanol as mobile phase at a flow rate of 1 mL min -1 . The detection wavelength was 230 nm and analysis was performed at room temperature. Hydrochlorothiazide was used as internal standard for both formulations. Plots of drug-to-internal standard peakarea ratios (response factor) against respective concentrations were linear in the range 3 to 20 µg mL -1 for AMB and in the range 1 to 11 µg mL -1 for CTZ and LCTZ. The method was precise (RSD < 2) and accurate for analysis of both drugs in pharmaceutical dosage forms. Statistical data and results from recovery studies were reported for both formulations.
Czasopismo
Rocznik
Tom
Strony
411--421
Opis fizyczny
Bibliogr. 17 poz., rys., tab.
Twórcy
autor
autor
autor
autor
autor
- J.S.S. College of Pharmacy Department of Pharmaceutical Analysis Post Box 20 Rocklands, Ooty 643001 Tamilnadu India, aruna_birajdar@rediffmail.com
Bibliografia
- [1] The Merck Index — An Encyclopedia of Chemicals, Drugs, and Biologicals, 11th edn, Merck Research Laboratories, Whitehouse Station, New Jersey, 1989, pp. 62, 310
- [2] J.H. Day, A.K. Eillis, and F. Rafeiro, Drugs Today (Barc), 40 , 415 (2004)
- [3] Z. Dincer, H. Basan, and N.G. Goger, J. Pharm. Biomed. Anal., 31 , 867 (2003)
- [4] J.E. Koundourellis, E.T. Malliou, and T.A. Broussali, J. Pharm. Biomed. Anal., 23 , 469 (2000)
- [5] J. Drozd, H. Hopkala, G. Misztal, and B. Paw, Acta. Pol. Pharm., 59 , 3 (2002)
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- [7] M.S. Arayne, N. Sultana, and F.A. Siddiqui, Pak. J. Pharm. Sci., 18 , 7 (2005)
- [8] A.M. Jaber, H.A. Al Sherife, M.M. Al Omari, and A.A. Badwan, J. Pharm. Biomed. Anal., 36 , 341 (2004)
- [9] B. Paw, G. Misztal, H. Hopkala, and J. Drozd, Pharmazie., 57 , 313 (2002)
- [10] A. Jelinska, B. Stanisz, M. Zajac, W. Musial, and A. Ostrowicz, Acta. Pol. Pharm., 57 , 171 (2000)
- [11] J. Moncrieff, J. Chromatogr. 583 , 128 (1992)
- [12] J. Macek, P. Ptacek, and J. Klima, J. Chromatogr. B, 736 , 231 (1999)
- [13] M.F. Zaater, Y.R. Tahboub, and N.M. Najib, J. Pharm. Biomed. Anal., 22 , 739 (2000)
- [14] M.R. Morita, D. Berton, R. Boldin, F.A.P. Barros, E.C. Meurer, A.R. Amarante, D.R. Campos, S.A. Calafatti, R. Pereira, E. Abib Jr, and J. Pedrazolli Jr, J. Chromatogr. B, 862 , 132 (2008)
- [15] ICH, Q2A: Text on Validation of Analytical Procedures, International Conference on Harmonization. October 1994
- [16] ICH, Q3B: Validation of Analytical Procedures: Methodology, International Conference on Harmonization, November 1996
- [17] L.R. Snyder, J.J. Kirkland, J.L. Glejch (Eds) Practical HPLC Method Development, Wiley-Interscience, New York, 1988, pp. 402–438.
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-article-BATE-0001-0032