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Development of Novel Stability-Indicating Method for the Determination of Dimethindene Maleate and Its Impurities

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Abstract

A novel and selective stability-indicating liquid chromatographic method has been developed and validated for the analysis of dimethindene maleate, the related substance 2-ethylpyridine, and three degradation products. Dimethindene maleate was subjected to forced degradation study by acid and basic hydrolysis, oxidation, and thermal decomposition. Three degradation products that were formed during the forced degradation study were separated from dimethindene using a Zorbax SB CN column (150 × 4.6 mm; 5 μm); cyanopropyl-bonded stationary phase was applied for the first time for the separation of dimethindene and its impurities. The proposed method was validated and was found suitable for quality control and stability tests of pharmaceuticals containing dimethindene maleate.

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References

  1. US Food and Drug Administration. http://www.fda.gov/downloads/Drugs/…/Guidances/ucm122858.pdf. Accessed 07 Jan 2013

  2. Klick S, Muijselaar PG, Waterval J, Eichinger T, Korn Ch, Gerding TK, Debets AJ, van de Griend KS, van den Beld C, Somsen GW, Jong GJD (2005) Toward a generic approach for stress testing of drug substances and drug products. Pharm Technol 2:48–66

    Google Scholar 

  3. Reynolds DW, Facchine KL, Mullaney JF, Alsante KM, Hatajik TD, Motto MG (2002) Available guidance and best practices for conducting forced degradation studies. Pharm Technol 2:48–56

    Google Scholar 

  4. Alsante KM, Martin L, Baertschi SW (2003) A stress testing benchmarking study. Pharm Technol 2:60–72

    Google Scholar 

  5. International Conference on Harmonization (ICH): Q1A(R2) stability testing of New Drug Substances and Products. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf. Accessed 19 Nov 2012

  6. Vetchý D, Frýbortová K, Rabišková M, Häring A (2006) Stability testing of medicinal preparations. Chem Listy 100(1):24–29

    Google Scholar 

  7. Matysová L, Havlíková L, Hájková R, Krivda A, Solich P (2009) Application of HILIC stationary phase to determination of dimethindene maleate in topical gel. J Pharma Biomed 50(1):23–26

    Article  Google Scholar 

  8. Viette V, Guillarme D, Mylonas R, Mauron Y, Fathi M, Rudaz S, Hochstrasser D, Veuthey J-L (2011) A multi-target screening analysis in human plasma using fast liquid chromatography–hybrid tandem mass spectrometry (Part I). Clin Biochem 44(1):32–44

    Article  CAS  Google Scholar 

  9. De Klerck K, Mangelings D, Clicq D, De Boever F, Heyden Y Vander (2012) Combined use of isopropylamine and trifluoroacetic acid in methanol-containing mobile phases for chiral supercritical fluid chromatography. J Chromatogr A 1234:72–79

    Article  Google Scholar 

  10. Younes AA, Mangelings D, Heyden Y Vander (2011) Chiral separations in normal phase liquid chromatography: enantioselectivity of recently commercialized polysaccharide-based selectors. Part I: enantioselectivity under generic screening conditions. J Pharma Biomed 55(3):414–423

    Article  CAS  Google Scholar 

  11. Younes AA, Mangelings D, Heyden Y Vander (2011) Chiral separations in normal-phase liquid chromatography: enantioselectivity of recently commercialized polysaccharide-based selectors. Part II. Optimization of enantioselectivity. J Pharma Biomed 56(3):521–537

    Article  CAS  Google Scholar 

  12. Younes AA, Mangelings D, Vander Heyden Y (2012) Chiral separations in reversed-phase liquid chromatography: evaluation of several polysaccharide-based chiral stationary phases for a separation strategy update. J Chromatogr A. doi:10.1016/j.chroma.2012.07.070

  13. Chankvetadze B (2012) Recent developments on polysaccharide-based chiral stationary phases for liquid-phase separation of enantiomers. J Chromatogr A. doi:10.1016/j.chroma.2012.10.033

    Google Scholar 

  14. Buchmann M, Kesselring UW (1978) Identification of principal products of dimethindene decomposition. Pharm Acta Helv 53(9–10):261–272

    CAS  Google Scholar 

  15. Buchmann M, Kesselring UW (1978) Decomposition products of dimethindene maleate. Pharm Acta Helv 53(11):301–306

    CAS  Google Scholar 

  16. Grand-Guillaume Perrenoud A, Boccard J, Veuthey J-L, Guillarme D (2012) Analysis of basic compounds by supercritical fluid chromatography: attempts to improve peak shape and maintain mass spectrometry compatibility. J Chromatogr A 1262:205–213

    Article  CAS  Google Scholar 

  17. Patel MA, Riley F, Ashraf-Khorassani M, Taylor LT (2012) Supercritical fluid chromatographic resolution of water soluble isomeric carboxyl/amine terminated peptides facilitated via mobile phase water and ion pair formation. J Chromatogr A 1233:85–90

    Article  CAS  Google Scholar 

  18. European Pharmacopoeia 7th Edition (2010) The Council of Europe, Strasbourg, France

  19. International Conference on Harmonization (ICH): Q2(R1) validation of analytical procedures: text and methodology. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html. Accessed 12 Nov 2012

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Acknowledgments

The authors gratefully acknowledge the financial support of the Charles University in Prague, project UNCE No. 204026/2012.

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Authors and Affiliations

  1. Department of Analytical Chemistry, Faculty of Pharmacy Charles University, Heyrovského 1203, 50005, Hradec Králové, Czech Republic

    Lucie Havlíková, Anna Pannyová, Ludmila Matysová & Petr Solich

Authors
  1. Lucie Havlíková
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  2. Anna Pannyová
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  3. Ludmila Matysová
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  4. Petr Solich
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Corresponding author

Correspondence to Ludmila Matysová.

Additional information

Published in the topical collection New Developments for the Sensitive and Validated Drug Analysis Using Chromatographic Methods with guest editor Sibel A. Ozkan.

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Havlíková, L., Pannyová, A., Matysová, L. et al. Development of Novel Stability-Indicating Method for the Determination of Dimethindene Maleate and Its Impurities. Chromatographia 76, 1545–1551 (2013). https://doi.org/10.1007/s10337-013-2449-z

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  • DOI: https://doi.org/10.1007/s10337-013-2449-z

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