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  • 1 National Organization for Drug Control and Research (NODCAR) 6 Abu Hazem Street, Pyramids Ave P.O. Box 29 35521 Giza Egypt
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Anovel economic procedure for stereospecific separation and analysis of ( R )-and ( S )-bupivacaine has been developed and validated. Use of different thin-layer chromatographic plates and different cyclodextrins at different temperatures was investigated. The spots were detected with either iodine vapor, or by use of a UV lamp followed by densitometric measurements at 262 nm. A comparative study was performed using different cyclodextrins — hydroxylpropyl-β-cyclodextrin (HP-β-CD), methyl-β-cyclodextrin (M-β-CD), and dimethyl-β-cyclodextrin (DM-β-CD) — as chiral selectors. The mobile phase enabling successful resolution of ( RS )-bupivacaine was acetonitrile-methanol-water 15:2.5:2.5 ( v/v ) containing 1 mM HP-β-CD; analysis was performed at ambient temperature (25 ± 2°C). The effect on resolution of the concentration of different chiral selectors, temperature, and pH was studied. Calibration plots for analysis of the R and S enantiomers were linear in the range 1.25–35.00 μg per spot ( r ≥ 0.9995, n = 6) with acceptable precision (RSD < 2.0%) and accuracy (RE = −1.5–2.8%). The limits of detection and quantification were 0.66 and 2.22 μg per spot, respectively, for ( R )-bupivacaine, and 0.88 and 2.94 μg per spot for ( S )-bupivacaine. The method is simple, selective, and robust, and can be used for identification and quantification of the enantiomers of bupivacaine in the drug substance and in pharmaceutical dosage forms.

  • The United Stated Pharmacopoeia “The National Formulary USP 30 ” United States Pharmacopoeial Convection Inc., 2007, 1562.

  • S.C. Sweetman , Martindale, The Extra Pharmacopoeia, 34 ed., Pharmaceutical Press, London, 2005, 1371, 1372, 1377.

    Sweetman S.C. , '', in Martindale, The Extra Pharmacopoeia , (2005 ) -.

  • L.L. Brunton, J.S. Lazo and K.L. Parker , Goodman and Gilman’s, The Pharmacological Basis of Therapeutics, 11 th Ed. McGrow-Hill, New York, USA, 2006, 377.

    Parker K.L. , '', in Goodman and Gilman’s, The Pharmacological Basis of Therapeutics , (2006 ) -.

    • Search Google Scholar
  • M. Van de Velde, R. Dreelinck, J. Dubois, A. Kumar, J. Deprest, L. Lewi , and F. Vandermeersch , Anesth. 106 (2007) 149–156.

    Vandermeersch F. , '' (2007 ) 106 Anesth. : 149 -156.

  • C.M. Moraes, P. Abrami, E. de Paula, A.F.A. Braga and L.F. Fracet , Int. J. Pharm. 331 (2007) 99–106.

    Fracet L.F. , '' (2007 ) 331 Int. J. Pharm. : 99 -106.

  • Z. Zhang, G. Yang, G. Liang, H. Liu and Y. Chen , J. Pharm. Biomed. Anal. 34 (2004) 689–693.

    Chen Y. , '' (2004 ) 34 J. Pharm. Biomed. Anal. : 689 -693.

  • A. Amini, U. P. Sorman, B. H. Lindgren and D. Westerlund , Electrophoresis 19 (1998) 731–737.

    Westerlund D. , '' (1998 ) 19 Electrophoresis : 731 -737.

  • M. Siluveru and J.T. Stewart , J. Pharm. Biomed. Anal. 4 (1996) 389–392.

    Stewart J.T. , '' (1996 ) 4 J. Pharm. Biomed. Anal. : 389 -392.

  • H.Y. Aboul-Enein, L.I. Abou-Basha and S.A. Bakr , Chirality 8 (1996) 153–156.

    Bakr S.A. , '' (1996 ) 8 Chirality : 153 -156.

  • K.I. Ozoemena, R.I. Stefan, J.F. van Staden and H.Y. Aboul-Enein , Sens. Actuators B 105 (2005) 425–429.

    Aboul-Enein H.Y. , '' (2005 ) 105 Sens. Actuators B : 425 -429.

  • D.W. Armstrong, Y. Liu and K.H. Ekborgott , Chirality 7 (1995) 474–497.

    Ekborgott K.H. , '' (1995 ) 7 Chirality : 474 -497.

  • D.W. Armstrong, Y. Tang and S. Chen , J. Chromatogr. 66 (1994) 1473–1484.

    Chen S. , '' (1994 ) 66 J. Chromatogr. : 1473 -1484.

  • S.G. Allenmark, S. Andersson, P. Moeller and D. Sanchez , Chirality 7 (1995) 248–256.

    Sanchez D. , '' (1995 ) 7 Chirality : 248 -256.

  • W. Muderawan, T.T. Ong and S.C. Ng , J. Sep. Sci. 29 (2006) 1849–1871.

    Ng S.C. , '' (2006 ) 29 J. Sep. Sci. : 1849 -1871.

  • S. Ivanildo, V. Vinícius, C. Marcos and S. Cesar , J. Adsorpt. 11 (2005) 123–129.

    Cesar S. , '' (2005 ) 11 J. Adsorpt. : 123 -129.

  • D.W. Armstrong, K.L. Rundlett and J.R. Chen , Chirality 6 (1994) 496–509.

    Chen J.R. , '' (1994 ) 6 Chirality : 496 -509.

  • S. Andersson, S. Allenmark, P. Moller, B. Persson and D. Sanchez , J. Chromatogr. A 741 (1996) 23–31.

    Sanchez D. , '' (1996 ) 741 J. Chromatogr. A : 23 -31.

  • C. Mil’anová and M. Hutta , J. Chromatogr. B 797 (2003) 91–109.

    Hutta M. , '' (2003 ) 797 J. Chromatogr. B : 91 -109.

  • A. Amini and U.P. Sorman , Electrophoresis 18 (2005) 1019–1025.

    Sorman U.P. , '' (2005 ) 18 Electrophoresis : 1019 -1025.

  • I. Abraham, J. Paul Fawcett, J. Kennedy, A. Kumar and R. Ledger , J. Chromatogr. B: Biomed. Sci. Appl. 703 (1997) 203–208.

    Ledger R. , '' (1997 ) 703 J. Chromatogr. B: Biomed. Sci. Appl. : 203 -208.

  • X.Q. Gu, B. Fryirs and L.E. Mather , J. Chromatogr. B: Biomed. Sci. Appl. 719 (1998) 135–140.

    Mather L.E. , '' (1998 ) 719 J. Chromatogr. B: Biomed. Sci. Appl. : 135 -140.

  • C. Rustichelli. V. Ferioli, G. Gamberini and R. Stancanelli , J. Chromatogr. 54 (2001) 731–736.

    Stancanelli R. , '' (2001 ) 54 J. Chromatogr. : 731 -736.

  • M. Siluveru and J.T. Stewart , Anal. Lett. 30 (1997) 1167–1178.

    Stewart J.T. , '' (1997 ) 30 Anal. Lett. : 1167 -1178.

  • A. Amini, E. Javerfalk, S. Bastami and D. Westerlund , Electrophoresis 20 (1999) 204–211.

    Westerlund D. , '' (1999 ) 20 Electrophoresis : 204 -211.

  • E.M. Javerfalk, A. Amini, D. Westerlund and P.E. Andren , J. Mass Spectrosc. 33 (1998) 183–186.

    Andren P.E. , '' (1998 ) 33 J. Mass Spectrosc. : 183 -186.

  • J.J. Martínez-Pla, Y. Martín-Biosca, S. Sagrado, R.M. Villanueva-Camańas and M.J. Medina-Hernández , J. Chromatogr. A 1048 (2004) 111–118.

    Medina-Hernández M.J. , '' (2004 ) 1048 J. Chromatogr. A : 111 -118.

  • E. Schneiderman and A.M. Stalcup , J. Chromatogr. B 745 (2000) 83–102.

    Stalcup A.M. , '' (2000 ) 745 J. Chromatogr. B : 83 -102.

  • H.Y. Aboul-Enein, M.I. El-Awady and C.H. Heard , J. Pharm. Biomed. Anal. 32 (2003) 1055–1059.

    Heard C.H. , '' (2003 ) 32 J. Pharm. Biomed. Anal. : 1055 -1059.

  • Clark’s Analysis of Drugs and Poisons in Pharmaceuticals, Body Fluids and Postmortem Material, third edition, Pharmaceutical Press, London, 2004, 392.

  • D.B. Pathare, A.S. Jadhav and M.S. Shingare , J. Pharm. Biomed. Anal. 41 (2006) 1152–1156.

    Shingare M.S. , '' (2006 ) 41 J. Pharm. Biomed. Anal. : 1152 -1156.

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