Authors:
Hanan Ahmed National Organization for Drug Control and Research (NODCAR) P.O. Box 29 12553 Cairo Egypt

Search for other papers by Hanan Ahmed in
Current site
Google Scholar
PubMed
Close
and
Nadia Youssef National Organization for Drug Control and Research (NODCAR) P.O. Box 29 12553 Cairo Egypt

Search for other papers by Nadia Youssef in
Current site
Google Scholar
PubMed
Close
Restricted access

A high-performance thin-layer chromatographic (HPTLC) method has been developed and validated as per ICH guidelines for simultaneous identification and quantification of the basic and acidic moieties of salmeterol xinafoate salt. Salmeterol xinafoate was split into two spots, salmeterol base and xinafoic acid at RF values 0.48 ± 0.02 and 0.36 ± 0.04, respectively, on pre-coated silica gel 60 F254 HPTLC plates using ethyl acetate-methanol-ammonia solution 33% (8:1.5:0.5 v/v) as a mobile phase. On the fluorescent plate, the spots were located by fluorescence quenching and spectrodensitometric quantification of salmeterol base was carried out at 300 nm and xinafoic acid at 250 nm under reflection-absorption mode. The calibration curves were linear in the range of 1–6 μg per spot for salmeterol base and 0.5–4 μg per spot for xinafoic acid with good correlation coefficients (0.9964, 0.9986), and percentage accuracy of 100.11 ± 0.84 and 99.13 ± 0.86, respectively. The proposed method was found to be reproducible for quantitative analysis of salmeterol xinafoate in drug substance, inhaled pharmaceutical dosage forms and spiked human urine and will serve in quality control analysis. Statistical analysis was performed and validation method has been estimated in terms of linearity range, limits of detection (LOD) and quantification (LOQ), accuracy and precision.

  • L.L. Brunton, J.S. Lazo, K.L. Parker, Goodman & Gilman’s, 11th edn., McGraw-Hill, New York, 2006, pp. 717, 720–728.

    Parker K.L. , '', in Goodman & Gilman’s , (2006 ) -.

  • S.C. Sweetman, Martindale: The Complete Drug Reference, 36th edn., The Pharmaceutical Press, London, 2009, p. 1135.1.

    Sweetman S.C. , '', in Martindale: The Complete Drug Reference , (2009 ) -.

  • British Pharmacopoeia, Her Majesty’s Stationary Office, London, 2009, p. 1812.

  • M. Zhang, J.P. Fawcett, J.P. Shaw, J. Chromatogr. B 729 (1999) 225–230.

    Shaw J.P. , '' (1999 ) 729 J. Chromatogr. B : 225 -230 .

  • A.F. Lehner, C.G. Hughes, W. Karpiesiuk, F.C. Camargo, J.D. Harkins, W.E. Woods, J. Bosken, J. Boyles, A. Troppmann, T. Tobin, Chromatographia 59 (2004) S79–S84.

    Tobin T. , '' (2004 ) 59 Chromatographia : S79 -S84 .

  • V.G. Nayak, S.G. Belapure, C.D. Gaitonde, A.A. Sule, J. Pharm. Biomed. Anal. 14 (1996) 511–513.

    Sule A.A. , '' (1996 ) 14 J. Pharm. Biomed. Anal. : 511 -513 .

  • A.S. Chilton, R.E. Godward, P.F. Carey, J. Pharm. Biomed. Anal. 13 (1995) 165–169.

    Carey P.F. , '' (1995 ) 13 J. Pharm. Biomed. Anal. : 165 -169 .

  • N.P. Sadler, H. Jacob, Talanta 42 (1995) 1385–1388.

    Jacob H. , '' (1995 ) 42 Talanta : 1385 -1388 .

  • M.N. Reddy, K.V. Rao-kanna, S.S. Rao, M.E.B. Rao, Indian Drugs 37 (2000) 105–107 through A. A. CD. Supplied by WHO (2006).

    Rao M.E.B. , '' (2000 ) 37 Indian Drugs : 105 -107 .

  • C. Vannecke, E. Van-Gyseghem, M.S. Bloomfield, T. Coomber, Y. Vander Heyden, D.L. Massart, Anal. Chim. Acta 446 (2001) 413–428.

    Massart D.L. , '' (2001 ) 446 Anal. Chim. Acta : 413 -428 .

  • K. Assi, B.J. Clark, K.D. Altria, Pharm. Sci. 3 (1997) 593–596.

    Altria K.D. , '' (1997 ) 3 Pharm. Sci. : 593 -596 .

  • A.C. Moffat, D. Osselton, B. Widdop, Clark’s Analysis of Drugs and Poisons, 3rd edn., The Pharmaceutical Press, London, 2004, p. 1550.

    Widdop B. , '', in Clark’s Analysis of Drugs and Poisons , (2004 ) -.

  • The United States Pharmacopoeia (32), National Formulary (27) Asian Edition, 2009, 733.

  • A.R. Gennaro, The Remington: The Science and Practice of Pharmacy, 21st edn., Lippincott Williams and Wilkins, Philadelphia, 2001, p. 138.

    Gennaro A.R. , '', in The Remington: The Science and Practice of Pharmacy , (2001 ) -.

  • R.S. Murray, J.S. Larry, Theory and Problems of Statistics, 3rd edn., McGraw-Hill, New York, 1999, p. 525.

    Larry J.S. , '', in Theory and Problems of Statistics , (1999 ) -.

  • Collapse
  • Expand

To see the editorial board, please visit the website of Springer Nature.

Manuscript Submission: HERE

For subscription options, please visit the website of Springer Nature.

Journal of Planar Chromatography - Modern TLC
Language English
Size A4
Year of
Foundation
1988
Volumes
per Year
1
Issues
per Year
6
Founder Akadémiai Kiadó
Founder's
Address
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Publisher Akadémiai Kiadó
Springer Nature Switzerland AG
Publisher's
Address
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
CH-6330 Cham, Switzerland Gewerbestrasse 11.
Responsible
Publisher
Chief Executive Officer, Akadémiai Kiadó
ISSN 0933-4173 (Print)
ISSN 1789-0993 (Online)

Monthly Content Usage

Abstract Views Full Text Views PDF Downloads
May 2024 3 0 0
Jun 2024 25 0 0
Jul 2024 24 0 0
Aug 2024 23 0 0
Sep 2024 37 0 0
Oct 2024 58 0 0
Nov 2024 4 0 0