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Determination of Prilocaine HCl in Pharmaceutical Preparations by GC-MS Method
Corresponding Author(s) : Yucel Kadioglu
Asian Journal of Chemistry,
Vol. 26 No. 19 (2014): Vol 26 Issue 19
Abstract
The novel analytical method using gas chromatography with mass spectrometry detection (GC-MS) method for determination of prilocaine HCl in pharmaceutical preparations were developed and validated. The using lidocaine HCl as the internal standard (IS) was carried out on HP-5MS capillary column. The calibration curves were linear (R = 0.999) in concentration range of 40-1000 ng/mL of prilocaine HCl. The LOD and LOQ values were 15 and 31 ng/mL, respectively. The within- and between-day RSD and RE % values of proposed method were found to be £ 3.4 and £ 3.5 %, respectively. o-Toluidine was formed in stored on auto sampler during 72 h was determined by proposed method. The developed method can be directly and easily applied for determination of prilocaine HCl without derivatized in pharmaceutical preparations using internal standard methodology.
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- B. Rishiraj, J.B. Epstein, D. Fine, S. Nabi and N.K. Wade, Int. J. Oral Maxillofac. Surg., 34, 220 (2005); doi:10.1016/j.ijom.2004.04.010.
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- K. Wiberg and S.P. Jacobsson, Anal. Chim. Acta, 514, 203 (2004); doi:10.1016/j.aca.2004.03.062.
- H.A. Adams, J. Biscoping, K. Ludof, A. Borgmann, B. Beckman-M and G. Hempelmann, Reg. Anaesth., 12, 53 (1989).
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- A. Asada, Osaka City Med. J., 25, 91 (1979).
- M. Prat, B. Clin. Chem., 32, 2098 (1986).
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R.A. Cawson, D.R. Curson and D.R. Whittington, Br. Dent. J., 154, 253 (1983); doi:10.1038/sj.bdj.4805046.
M. Siluveru and J.T. Stewart, J. Chromatogr. B, 693, 205 (1997); doi:10.1016/S0378-4347(97)00017-0.
J.Y. Jastak, J.A. Yagela and D. Donaldson, In: Pharmacology of Local Anesthesia and Clinical Preparations and Drug Selection, Philadelphia: WB Saunders, p. 23 (1995).
R.E. Warren, T.B. Van de Mark and S. Weinberg, Oral Surg. Oral Med. Oral Pathol., 37, 866 (1974); doi:10.1016/0030-4220(74)90439-3.
E.J. Ariens, in ed.: A.M. Krstulovic, In: Chiral Separation in HPLC, Applications to Pharmaceutical Compounds, Ellis Harwood, W. Sussex, p. 31 (1989).
B. Rudlof, D. Durstewitz-Knierim, I. Ridderskamp, C. Scharenberg and L. Brandt, Anaesthesist, 44, 445 (1995); doi:10.1007/s001010050175.
M. Siluveru and J.T. Stewart, J. Pharm. Biomed. Anal., 15, 389 (1996); doi:10.1016/S0731-7085(96)01872-9.
A. Taddio, B. Stevens, K. Craig, P. Rastogi, S. BenDavid, A. Shennan, P. Mulligan and G. Koren, N. Engl. J. Med., 336, 1197 (1997); doi:10.1056/NEJM199704243361701.
G.T. Tucker, L.E. Mather, M.S. Lennard and A. Gregory, Br. J. Anaesth., 65, 333 (1990); doi:10.1093/bja/65.3.333.
R. Whelpton, P. Dudson, H. Cannell and K. Webster, J. Chromatogr. A, 526, 215 (1990); doi:10.1016/S0378-4347(00)82501-3.
K. Wiberg, M. Andersson, A. Hagman and S.P. Jacobsson, J. Chromatogr. A, 1029, 13 (2004); doi:10.1016/j.chroma.2003.12.052.
L.M. Storms and J.T. Stewart, J. Pharm. Biomed. Anal., 30, 49 (2002); doi:10.1016/S0731-7085(02)00195-4.
K. Wiberg and S.P. Jacobsson, Anal. Chim. Acta, 514, 203 (2004); doi:10.1016/j.aca.2004.03.062.
H.A. Adams, J. Biscoping, K. Ludof, A. Borgmann, B. Beckman-M and G. Hempelmann, Reg. Anaesth., 12, 53 (1989).
Z. Fijalek, E. Baczynski, A. Piwonska and M. Warowna-Grzeskiewicz, J. Pharm. Biomed. Anal., 37, 913 (2005); doi:10.1016/j.jpba.2004.09.025.
E. Bacynski, A. Piwonska and Z. Fijalek, Pol. Pharm., 59, 333 (2002).
J. Klein, D. Fernandes, M. Gazarian, G. Kent and G. Koren, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 655, 83 (1994); doi:10.1016/0378-4347(94)00062-X.
M.A.-A. Mohammad, Chromatographia, 70, 563 (2009); doi:10.1365/s10337-009-1173-1.
A. Koehler, R. Oertel and W. Kirch, J. Chromatogr. A, 1088, 126 (2005); doi:10.1016/j.chroma.2005.03.071.
J. Klimundova, D. Satinsky, H. Sklenarova and P. Solich, Talanta, 69, 730 (2006); doi:10.1016/j.talanta.2005.11.011.
P. Norouzi, M.R. Ganjali, R. Dinarvand, M.H. Eshraghi and H.A. Zamani, Russ. J. Electrochem., 46, 999 (2010); doi:10.1134/S1023193510090053.
T. Watanabe, A. Namera, M. Yashiki, Y. Iwasaki and T. Kojima, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 709, 225 (1998); doi:10.1016/S0378-4347(98)00081-4.
Y. Kadioglu and A. Atila, Biomed. Chromatogr., 21, 1077 (2007); doi:10.1002/bmc.857.
A. Asada, Osaka City Med. J., 25, 91 (1979).
M. Prat, B. Clin. Chem., 32, 2098 (1986).
E.F. Salim and B. Örtenblad, J. Pharm. Sci., 56, 1645 (1967); doi:10.1002/jps.2600561221.
J.D. Cameron, Clin. Chim. Acta, 56, 307 (1974); doi:10.1016/0009-8981(74)90144-2.
M. Björk, K.-J. Pettersson and G. Österlöf, J. Chromatogr. A, 533, 229 (1990); doi:10.1016/S0378-4347(00)82207-0.
O.W. Lau, K. Chan and Y.C. Wong, Reg. Anaesth., 13, 118 (1990).
Y. Kadioglu and A. Atila, Chromatographia, 67, 755 (2008); doi:10.1365/s10337-008-0596-4.
Validation of Analytical Procedures, Proceedings of the International Conference on Harmonisation (ICH), Commission of the European Communities (1996).
K. Gaber, U.A. Harreus, C. Matthias, N.H. Kleinsasser and E. Richter, Toxicology, 229, 157 (2007); doi:10.1016/j.tox.2006.10.012.