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Journal of Analytical Methods in Chemistry
Volume 2018, Article ID 4526396, 8 pages
https://doi.org/10.1155/2018/4526396
Research Article

A Robust Static Headspace GC-FID Method to Detect and Quantify Formaldehyde Impurity in Pharmaceutical Excipients

1Department of Pharmaceutical Chemistry and Quality Control, Faculty of Pharmacy, Damascus University, Damascus, Syria
2Department of Chemistry, Faculty of Science, Damascus University, Damascus, Syria

Correspondence should be addressed to Bashir Daoud Agha Dit Daoudy; moc.liamtoh@yduoad-rihsab

Received 20 June 2017; Accepted 17 October 2017; Published 4 March 2018

Academic Editor: Krishna K. Verma

Copyright © 2018 Bashir Daoud Agha Dit Daoudy et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. A. S. Narang and S. H. Boddu, Excipient Applications in Formulation Design and Drug Delivery, Springer International Publishing, Basel, Switzerland, 2015.
  2. M. Li, Organic Chemistry of Drug Degradation, Royal Society of Chemistry, Cambridge, UK, 2012.
  3. R. P. Gullapalli and C. L. Mazzitelli, “Polyethylene glycols in oral and parenteral formulations—a critical review,” International Journal of Pharmaceutics, vol. 496, no. 2, pp. 219–239, 2015. View at Publisher · View at Google Scholar · View at Scopus
  4. K. K. Hotha, S. Roychowdhury, and V. Subramanian, “Drug-excipient interactions: case studies and overview of drug degradation pathways,” American Journal of Analytical Chemistry, vol. 7, no. 1, pp. 107–140, 2016. View at Publisher · View at Google Scholar
  5. British Pharmacopeia, British Pharmacopeia Commission, London, UK, 2013.
  6. USP, The United States Pharmacopeia, USP 39-NF 34, United States Pharmacopeial Convention, Rockville, MD, USA, 2016.
  7. S. T. Colgan, T. C. Zelesky, R. Chen et al., “Use of activated carbon in packaging to attenuate formaldehyde-induced and formic acid–induced degradation and reduce gelatin cross-linking in solid dosage forms,” Journal of Pharmaceutical Sciences, vol. 105, no. 7, pp. 2027–2031, 2016. View at Publisher · View at Google Scholar · View at Scopus
  8. K. C. Waterman, W. B. Arikpo, M. B. Fergione et al., “N-methylation and N-formylation of a secondary amine drug (varenicline) in an osmotic tablet,” Journal of Pharmaceutical Sciences, vol. 97, no. 4, pp. 1499–1507, 2008. View at Publisher · View at Google Scholar · View at Scopus
  9. G. Wang, J. D. Fiske, S. P. Jennings, F. P. Tomasella, V. A. Palaniswamy, and K. L. Ray, “Identification and control of a degradation product in Avapro™ film-coated tablet: Low dose formulation,” Pharmaceutical Development and Technology, vol. 13, no. 5, pp. 393–399, 2008. View at Publisher · View at Google Scholar · View at Scopus
  10. M. Douša, P. Gibala, J. Havlíček, L. Plaček, M. Tkadlecová, and J. Břicháč, “Drug-excipient compatibility testing—identification and characterization of degradation products of phenylephrine in several pharmaceutical formulations against the common cold,” Journal of Pharmaceutical and Biomedical Analysis, vol. 55, no. 5, pp. 949–956, 2011. View at Publisher · View at Google Scholar · View at Scopus
  11. Q. Zhong, S. Stowers, N. L. Segraves et al., “Degradation of a pharmaceutical in HPLC grade methanol containing trace level formaldehyde,” Pharmaceutical Development and Technology, vol. 18, no. 4, pp. 877–882, 2013. View at Publisher · View at Google Scholar · View at Scopus
  12. B. L. Williamson, A. J. Tomlinson, P. K. Mishra, G. J. Gleich, and S. Naylor, “Structural characterization of contaminants found in commercial preparations of melatonin: similarities to case-related compounds from L-tryptophan associated with eosinophilia-myalgia syndrome,” Chemical Research in Toxicology, vol. 11, no. 3, pp. 234–240, 1998. View at Publisher · View at Google Scholar · View at Scopus
  13. P. K. Ragham and K. B. Chandrasekhar, “A rapid UPLC-UV method development and validation for the quantitative determination of formaldehyde using derivatization technique,” International Journal of Research in Pharmaceutical Sciences, vol. 6, no. 2, pp. 46–53, 2015. View at Google Scholar
  14. W. M. Haynes, CRC Handbook of Chemistry and Physics, CRC Press, Boca Raton, FL, USA, 93rd edition, 2012.
  15. J. N. Hemenway, T. C. Carvalho, V. M. Rao et al., “Formation of reactive impurities in aqueous and neat polyethylene glycol 400 and effects of antioxidants and oxidation inducers,” Journal of Pharmaceutical Sciences, vol. 101, no. 9, pp. 3305–3318, 2012. View at Publisher · View at Google Scholar · View at Scopus
  16. M. A. del Barrio, J. Hu, P. Zhou, and N. Cauchon, “Simultaneous determination of formic acid and formaldehyde in pharmaceutical excipients using headspace GC/MS,” Journal of Pharmaceutical and Biomedical Analysis, vol. 41, no. 3, pp. 738–743, 2006. View at Publisher · View at Google Scholar · View at Scopus
  17. A. Teasdale, Genotoxic Impurities: Strategies for Identification and Control, John Wiley & Sons, Hoboken, NJ, USA, 2011.
  18. S. Zali, F. Jalali, A. Es-haghi, and M. Shamsipur, “Determination of free formaldehyde in vaccines and biological samples using solid-phase microextraction coupled to GC–MS,” Journal of Separation Science, vol. 36, no. 24, pp. 3883–3888, 2013. View at Publisher · View at Google Scholar · View at Scopus
  19. Z. Li, B. M. Kozlowski, and E. P. Chang, “Analysis of aldehydes in excipients used in liquid/semi-solid formulations by gas chromatography–negative chemical ionization mass spectrometry,” Journal of Chromatography A, vol. 1160, no. 1-2, pp. 299–305, 2007. View at Publisher · View at Google Scholar · View at Scopus
  20. Z. Li, L. K. Jacobus, W. P. Wuelfing, M. Golden, G. P. Martin, and R. A. Reed, “Detection and quantification of low-molecular-weight aldehydes in pharmaceutical excipients by headspace gas chromatography,” Journal of Chromatography A, vol. 1104, no. 1-2, pp. 1–10, 2006. View at Publisher · View at Google Scholar · View at Scopus
  21. G. J. Manius, L. F. Wen, and D. Palling, “Three approaches to the analysis of trace formaldehyde in bulk and dosage form pharmaceuticals,” Pharmaceutical Research, vol. 10, no. 3, pp. 449–453, 1993. View at Google Scholar
  22. A. Nageswari, K. V. S. R. K. Reddy, and K. Mukkanti, “Low-level quantitation of formaldehyde in drug substance by HPLC–UV,” Chromatographia, vol. 75, no. 5-6, pp. 275–280, 2012. View at Publisher · View at Google Scholar · View at Scopus
  23. S. Velankar, R. Lokhande, R. Yadav, and R. Pawar, “HPLC method development and validation for determination of formaldehyde and acetaldehyde traces in drug substance,” International Journal of Chemical and Pharmaceutical Analysis, vol. 3, no. 4, 2016. View at Google Scholar
  24. B. Kolb and L. S. Ettre, Static Headspace-Gas Chromatography: Theory and Practice, John Wiley & Sons, New York, NY, USA, 2nd edition, 2006.
  25. C. F. Poole, Gas Chromatography, Elsevier, Waltham, MA, USA, 1st edition, 2012.
  26. J. Clayden, N. Greeves, and S. Warren, Organic Chemistry, Oxford University Press, New York, NY, USA, 2nd edition, 2012.
  27. R. C. Rowe, P. J. Sheskey, and M. E. Quinn, Handbook of Pharmaceutical Excipients, Pharmaceutical Press, London, UK, 6th edition, 2009.