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Validated gradient high-performance liquid chromatography-diode array detection (HPLC-DAD) method has been developed for simultaneous determination of diloxanide furoate (DIL), mebeverine hydrochloride (MBV), and metronidazole (MET) in their pharmaceutical preparation. This method was based on a reversed-phase HPLC separation of the cited drugs on a C-18 column (150 mm × 4.6 mm, 5 μm) with a gradient elution system of 0.05 M phosphate buffer with 1% (v/v) of triethylamine adjusted to pH 3.0-methanol as the mobile phase at the flow rate of 1.0 mL min -1. The separation was carried out at ambient temperature. Quantitation was achieved with DAD detection at 260 nm for DIL and MEB, and at 320 for MET based on peak area with linear calibration curves at concentration ranges 4–30, 1–20, and 1–30 μg mL -1 for DIL, MEB, and MET, respectively. The proposed chromatographic method was successfully applied to the determination of the investigated drugs in pharmaceutical preparation. It was validated in compliance with International Conference on Harmonization (ICH) guidelines, in terms of linearity, accuracy, precision, robustness, limits of detection, and quantitation and other aspects of analytical validation.
Czasopismo
Rocznik
Tom
Strony
67--80
Opis fizyczny
Bibliogr. 12 poz., rys., tab.
Twórcy
autor
- University of Alexandria Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry El-Messalah, Alexandria 21521 Egypt
Bibliografia
- [1] British Pharmacopoeia, HMSO: London, 2007
- [2] The United States Pharmacopeia and National Formulary, The Official Compendia of Standards, Asian Edition, USP 30-NF 25, Rockville, MD, 2007
- [3] J.G.F. Reynolds, The Extra Pharmacopoeia, The Pharmaceuticals Press Martindale, London 1988
- [4] Martindale: Extra Pharmacopoeia, 34th edn, The Complete Drug References, The Pharmaceutical Press, London, UK, 2005
- [5] J.G. Hardman and L.E. Limbird, Goodman & Gillman’s, The Pharmacological Basis of Therapeutics, 9th edn, McGraw, Hill, New York, 1996
- [6] S. Budavaried, The Merck Index, an Encyclopedia of Chemicals, Drugs and Biologicals, 14th edn, Merck & Co., Inc., Whitehouse Station, NJ, USA, 2006
- [7] M. El-Ghobashy and N. Abo-Talib, Bull. Fac. Pharm. Cairo Univ., 46(1), 75–86 (2008).
- [8] L.R. Snyder, J.L. Glajch, and J.J. Kirkland, Practical HPLC Method Development, John Wiley & Sons Inc., New York, 1988
- [9] ICH, Q2 (R1) Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonization, Geneva, 2005
- [10] A.C. Moffat, M.D. Osselton, and B. Widdop, Clarke’s Analysis of Drugs and Poisons, 3rd Edition, London, 2004
- [11] J.N. Miller and JC. Miller, Statistics and Chemometrics for Analytical Chemistry, 4th Edition, Prentice Hall, Harlow, England, 2000
- [12] FDA. Center for Drug Evaluation Research (CDER), Reviewer Guidance: Validation of Chromatographic Methods, Washington, USA, 1994
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-4041a2c7-6cc8-4b0f-8cb6-f7eb44054e2b