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Simple, fast, and sensitive isocratic high-performance liquid chromatography method for the quantification of latanoprost

Autorzy
Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
A simple, sensitive, fast, and accurate isocratic high-performance liquid chromatography (HPLC) method with UV detection (205 nm) has been developed and validated for the quantification of latanoprost (in nanogram level) in pure and commercial dosage form. An Agilent Eclipse XDB-C18 column (150 × 4.6 mm i.d., 3.5 μm particle size) was used. Chromatography was performed with a mobile phase containing a mixture of acetonitrile and water (70:30, v/v) containing 0.1% v/v trifluoroacetic acid, adjusted at pH 3.0 at a flow rate of 1 mL min-1. Each analysis required 3.0 min including triamcinolone acetonide as an internal standard. The method was validated for linearity, accuracy, precision, specificity, system suitability, and robustness. The calibration curve was linear in the concentration range 0.0125–1 μg mL-1; the correlation coefficient was 0.999. The method proved to be accurate, precise, specific, rapid, and reproducible according to ICH standards. The method showed good recoveries (average 100.15 %), and the relative standard deviations of intra- and inter-day were <2.0%. This method is novel since there has been no report about analysis of latanoprost at ng mL-1 levels using a simple HPLC method. Besides regular quality control assay of latanoprost in raw material and in commercial formulations, this method has key importance for scientists working on sustained drug delivery system of latanoprost in which quantification in nanogram levels is one of the most important parameters.
Rocznik
Strony
191--202
Opis fizyczny
Bibliogr. 25 poz., rys., tab.
Twórcy
autor
  • Georgia Institute of Technology School of Chemical and Biomolecular Engineering Atlanta GA 30332-0100 USA
autor
  • Georgia Institute of Technology School of Chemical and Biomolecular Engineering Atlanta GA 30332-0100 USA
  • Gulhane Military Medical Academy Department of Pharmaceutical Sciences 06018 Etlik, Ankara Turkey
Bibliografia
  • [1] J. Stjernschantz and B. Resul, Drugs Future, 17, 691 (1992)
  • [2] B. Resul, J. Stjernschantz, K. No, C. Liljebria, G. Selen, M. Astin, M. Karlsson, and L.Z. Bito, J Med. Chem., 36, 243 (1993)
  • [3] S. Basu, B. Sjöquist, J. Stjernschantz, and B. Resul, Prostaglandins, Leukotrienes Essent. Fatty Acids, 50, 161 (1994)
  • [4] B. Sjöquist, S. Basu, K. Bergh, and P. Byding, Exp. Eye Res., 59(Suppl 1), 146 (1994)
  • [5] B.T. Gabelt and P.L. Kaufman, Exp. Eye Res., 49, 389 (1989)
  • [6] P.L. Kaufman and K. Crawford, Prog. Clin. Biol. Res., 312, 387 (1989)
  • [7] S.F. Nilsson, M. Samuelsson, A. Bill, and J. Stjernschantz, Exp. Eye Res., 48, 707 (1989)
  • [8] K. Higaki, K. Kamata, M. Takeuchi, K. Inazawa, T. Chikai, T. Hamaguchi, T. Yukawa, K. Kadono, S. Kawahara, and M. Nakano, Drug Metab. Dispos., 23, 35 (1995)
  • [9] S. Basu and B. Sjöquist, Prostaglandins, Leukotrienes Essent. Fatty Acids, 55, 427 (1996)
  • [10] B. Sjöquist, S. Basu, P. Byding, K. Bergh, and J. Stjernschantz, Drug Metab. Dispos., 26, 745 (1998).
  • [11] B. Sjöquist and J. Stjernschantz, Surv. Ophthalmol., 47Suppl 1, 6 (2002)
  • [12] B. Sjöquist, A. Uhlin, P. Byding, and J. Stjernschantz, Arzneimittelforschung, 49, 234 (1999)
  • [13] B. Calissendorff, B. Sjöquist, G. Hogberg, and A. Grunge-Lowerud, J. Ocul. Pharmacol. Ther., 18, 127 (2002)
  • [14] V. Redulescu, C. Doneanu, C. Mandruta, and F. Cocu, Rev. Roum. Chim., 42, 1129 (1997)
  • [15] P.V. Morgan, S. Proniuk, J. Blanchard, and R.J. Noecker, J. Glaucoma, 10, 401 (2001)
  • [16] Y. Sakai, S. Yasueda, and A. Ohtori, Int. J. Pharm., 305, 176 (2005)
  • [17] R. Varma, J. Winarko, T. Kiat-Winarko, and B. Winarko, Invest. Ophthalmol. Visual Sci., 47, 222 (2006)
  • [18] M. Ashfaq, I.U. Khan, and M.N. Asghar, Anal. Lett., 39, 2235 (2006)
  • [19] P. Widomski, P. Baran, P. Golebiewski, I. Surowiec, and A. Bielejewska, Acta Chromatogr., 20, 157 (2008)
  • [20] M.D. Paolera, N. Kasahara, C.C. Umbelino, and J.G. Walt, BMC Ophthalmol., 8, 11 (2008)
  • [21] ICH Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology, 1996
  • [22] G.A. Shabir, J. Chromatogr. A, 987, 57 (2003)
  • [23] G.A. Shabir, Separation Sci. Tech., 45, 670 (2010)
  • [24] U.S. Pharmacopeia 32, Chromatography, Section (621), United States Pharmacopeial Convention, Rockville Maryland, 2009, p. 1776
  • [25] C. Akay, I.T. Degim, A. Sayal, A. Aydin, Y. Ozkan, and H. Gul, Turk J. Med. Sci., 38, 161 (2008)
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-a1fcc480-8e7a-480c-a086-70afbbc2a58d
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