About this Journal Submit a Manuscript Table of Contents
ISRN Chromatography
Volume 2013 (2013), Article ID 506923, 12 pages
http://dx.doi.org/10.1155/2013/506923
Research Article

Development and Validation of a Stability Indicating RP-HPLC Method for the Determination of Two Sun Protection Factors (Koptrizon and Tinosorb S) in Topical Pharmaceutical Formulations Using Experimental Designs

1Analytical Research and Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad, Andhra Pradesh 500090, India
2Department of Chemistry, National Institute of Technology, Durgapur, West Bengal 713209, India

Received 11 March 2013; Accepted 15 April 2013

Academic Editors: C. Akbay and J. A. P. Coelho

Copyright © 2013 Chinmoy Roy and Jitamanyu Chakrabarty. 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. Chisvert, M. C. Pascaul-Marti, and A. Salvador, “Determination of the UV filters worldwideauthorized in sunscreens by HPLC Use of cyclodextrins as mobile phase modifier,” Journal of Chromatography A, vol. 921, no. 2, pp. 207–215, 2001.
  2. C. Couteau, A. Faure, J. Fortin, E. Paparis, and L. J. M. Coiffard, “Study of the photostability of 18 sunscreens in creams by measuring the SPF in vitro,” Journal of Pharmaceutical and Biomedical Analysis, vol. 44, no. 1, pp. 270–273, 2007. View at Publisher · View at Google Scholar · View at Scopus
  3. A. Salvador and A. Chisvert, “Sunscreen analysis: a critical survey on UV filters determination,” Analytica Chimica Acta, vol. 537, no. 1-2, pp. 1–14, 2005. View at Publisher · View at Google Scholar · View at Scopus
  4. B. A. Gilchrest, N. A. Soter, J. L. Hawk et al., “Histological changes associated with ultraviolet A-induced erythema in normal human skin,” Journal of the American Academy of Dermatology, vol. 9, no. 2, pp. 213–219, 1983.
  5. T. Takeuchi, J. Uitto, and E. F. Bernstein, “A novel in vivo model for evaluating agents that protect against ultraviolet A-induced photoaging,” Journal of Investigative Dermatology, vol. 110, no. 4, pp. 343–347, 1998. View at Publisher · View at Google Scholar · View at Scopus
  6. J. M. Menter, A. M. Patta, R. M. Sayre, J. Dowdy, and I. Willis, “Effect of UV irradiation on type I collagen fibril formation in neutral collagen solutions,” Photodermatology Photoimmunology and Photomedicine, vol. 17, no. 3, pp. 114–120, 2001. View at Publisher · View at Google Scholar · View at Scopus
  7. 2010, http://www.who.int/uv/sun_protection/en/.
  8. A. Rampaul, I. P. Parkin, and L. P. Cramer, “Damaging and protective properties of inorganic components of sunscreens applied to cultured human skin cells,” Journal of Photochemistry and Photobiology A, vol. 191, no. 2-3, pp. 138–148, 2007. View at Publisher · View at Google Scholar · View at Scopus
  9. L. M. Peruchi and S. Rath, “Development and application of a HPLC method for eight sunscreen agents in suncare products,” International Journal of Cosmetic Science, vol. 34, no. 1, pp. 226–233, 2012. View at Publisher · View at Google Scholar
  10. J. Flor, M. R. Davolos, and M. A. Correa, “Sunscreens,” Quimica Nova, vol. 30, no. 1, pp. 153–158, 2007. View at Publisher · View at Google Scholar · View at Scopus
  11. H. M. Chawla and S. Mrig, “Simultaneous quantitative estimation of oxybenzone and 2-ethylhexyl-4- methoxycinnamate in sunscreen formulations by second order derivative spectrophotometry,” Journal of Analytical Chemistry, vol. 64, no. 6, pp. 585–592, 2009. View at Publisher · View at Google Scholar · View at Scopus
  12. E. Westgate and J. Sherma, “Determination of the sunscreen oxybenzone in lotions by reversed-phase HPTLC with ultraviolet absorption densitometry,” Journal of Liquid Chromatography and Related Technologies, vol. 23, no. 4, pp. 609–615, 2000. View at Publisher · View at Google Scholar · View at Scopus
  13. A. W. Sobanska and E. Brzezinska, “Normal-phase TLC analysis of UV filters avobenzone and octocrylene in sunscreen preparations,” Journal of Planar Chromatography, vol. 24, no. 2, pp. 154–159, 2011. View at Publisher · View at Google Scholar · View at Scopus
  14. K. Ikeda, S. Suzuki, and Y. Watanabe, “Determination of sunscreen agents in cosmetic products by reversed-phase high-performance liquid chromatography,” Journal of Chromatography, vol. 513, pp. 321–326, 1990.
  15. L. Dencausse, A. Galland, J. L. Clamou, and J. Basso, “Validation of HPLC method for quantitative determination of Tinosorb®S and three other sunscreens in a high protection cosmetic product,” International Journal of Cosmetic Science, vol. 30, no. 5, pp. 373–382, 2008. View at Publisher · View at Google Scholar · View at Scopus
  16. A. Salvador and A. Chisvert, “An environmentally friendly (“green”) reversed-phase liquid chromatography method for UV filters determination in cosmetics,” Analytica Chimica Acta, vol. 537, no. 1-2, pp. 15–24, 2005. View at Publisher · View at Google Scholar · View at Scopus
  17. E. R. M. Kedor-Hackmann, M. L. De Lourdes Pérez González, A. K. Singh, and M. I. R. M. Santoro, “Validation of a HPLC method for simultaneous determination of five sunscreens in lotion preparation,” International Journal of Cosmetic Science, vol. 28, no. 3, pp. 219–224, 2006. View at Publisher · View at Google Scholar · View at Scopus
  18. S. Scalia, “Determination of sunscreen agents in cosmetic products by supercritical fluid extraction and high-performance liquid chromatography,” Journal of Chromatography A, vol. 870, no. 1-2, pp. 199–205, 2000. View at Publisher · View at Google Scholar · View at Scopus
  19. S. Simeoni, R. Tursilli, A. Bianchi, and S. Scalia, “Assay of common sunscreen agents in suncare products by high-performance liquid chromatography on a cyanopropyl-bonded silica column,” Journal of Pharmaceutical and Biomedical Analysis, vol. 38, no. 2, pp. 250–255, 2005. View at Publisher · View at Google Scholar · View at Scopus
  20. M. Nyeborg, M. Pissavini, Y. Lemasson, and O. Doucet, “Validation of HPLC method for the simultaneous and quantitative determination of 12 UV-filters in cosmetics,” International Journal of Cosmetic Science, vol. 32, no. 1, pp. 47–53, 2010. View at Publisher · View at Google Scholar · View at Scopus
  21. M. Wharton, M. Geary, N. O'Connor, and B. Murphy, “A rapid High Performance Liquid Chromatographic (HPLC) method for the simultaneous determination of seven UV filters found in sunscreen and cosmetics,” International Journal of Cosmetic Science, vol. 33, no. 2, pp. 164–170, 2011. View at Publisher · View at Google Scholar · View at Scopus
  22. F. M. P. Vilela, Y. M. Fonseca, F. T. M. C. Vicentini, M. J. V. Fonseca, and M. D. P. H. Do Amaral, “Determination of three ultraviolet filters in sunscreen formulations and from skin penetration studies by high-performance liquid chromatography,” Quimica Nova, vol. 34, no. 5, pp. 879–883, 2011. View at Publisher · View at Google Scholar · View at Scopus
  23. A. W. Sobanska and J. Pyzowski, “Quantification of sunscreen ethylhexyl triazone in topical skin-care products by normal-phase TLC/densitometry,” Scientific World Journal, vol. 2012, Article ID 807516, 6 pages, 2012. View at Publisher · View at Google Scholar
  24. G. Potard, C. Laugel, H. Schaefer, and J. P. Marty, “The stripping technique: in vitro absorption and penetration of five UV filters on excised fresh human skin,” Skin Pharmacology and Applied Skin Physiology, vol. 13, no. 6, pp. 336–344, 2000. View at Scopus
  25. G. Potard, C. Laugel, A. Baillet, H. Schaefer, and J. P. Marty, “Quantitative HPLC analysis of sunscreens and caffeine during in vitro percutaneous penetration studies,” International Journal of Pharmaceutics, vol. 189, no. 2, pp. 249–260, 1999. View at Publisher · View at Google Scholar · View at Scopus
  26. M. D. Bleasel and S. Aldous, “In vitro evaluation of sun protection factors of sunscreen agents using a novel UV spectrophotometric technique,” International Journal of Cosmetic Science, vol. 30, no. 4, pp. 259–270, 2008. View at Publisher · View at Google Scholar · View at Scopus
  27. Uvinul grades, UV absorbers for cosmetic products, BASF technical information.
  28. G. Vielhaber, S. Grether-Beck, O. Koch, W. Johncock, and J. Krutmann, “Sunscreens with an absorption maximum of ≥360 nm provide optimal protection against UVA1-induced expression of matrix metalloproteinase-1, interleukin-1, and interleukin-6 in human dermal fibroblasts,” Photochemical and Photobiological Sciences, vol. 5, no. 3, pp. 275–282, 2006. View at Publisher · View at Google Scholar · View at Scopus
  29. E. Chatelain and B. Gabard, “Photostabilization of butyl methoxydibenzoylmethane (Avobenzone) and Ethylhexyl methoxycinnamate by bis-ethylhexyloxyphenol methoxyphenyl triazine (Tinosorb S), a new UV broadband filter,” Photochemical and Photobioogical Sciences, vol. 74, no. 3, pp. 401–406, 2001.
  30. http://www.ciba.com/tinosorb-s_brochure.pdf.
  31. C. Couteau, M. Pommier, E. Paparis, and L. J. M. Coiffard, “Study of the efficacy of 18 sun filters authorized in European Union tested in vitro,” Pharmazie, vol. 62, no. 6, pp. 449–452, 2007. View at Publisher · View at Google Scholar · View at Scopus
  32. ICH Q1A (R2), “Stability Testing of new Drug Substances and Products,” in Proceedings of the International Conference on Harmonization, 2003.
  33. ICH Q2 (R1), “Validation of analytical procedures: text and methodology,” in Proceedings of the International Conference on Harmonization, 2005.
  34. J. Peterson, “Statistical Analysis QbD Classics: What Your ICH Q8 Design Space Needs,” Pharma Qbd, 2010.
  35. U. Smith, “Optimizing Design of Experiments for Fluid Bed Coating,” Pharma Qbd, 2010.
  36. M. Anderson, “Design space, Framing a QbD Design Space with Tolerance Intervals,” Pharma Qbd, 2012.