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A Comparison of Analytical Methods for the Content and Purity of Cefradine

  • Hyun, Myung-Ho (Department of Chemistry and Chemistry Institute for Functional Materials, Pusan National University) ;
  • Jeong, Euh-Duck (High-Technology Components & Materials Research Center & Busan Center, Korea Basic Science Institute (KBSI)) ;
  • Shin, Min-Seob (Department of Chemistry and Chemistry Institute for Functional Materials, Pusan National University) ;
  • Jin, Jong-Sung (High-Technology Components & Materials Research Center & Busan Center, Korea Basic Science Institute (KBSI))
  • Published : 2008.06.20

Abstract

Two HPLC methods such as cefadroxil and cefalexin methods were compared in their performance for the quantitative analysis of the content and purity of $\beta$ -lactamic antibiotic, cefradine, for six bulk drug samples. Between the two methods, the cefadroxil method prescribed by the European Pharmacopoeia (EP) for the determination of impurities in cefradoxil was superior to the cefalexin method prescribed by the EP and by the United States Pharmacopeia (USP) for the determination of cefalexin impurity in cefradine in terms of the greater stability of the chromatogram baselines and the higher precision, i.e., the lower % relative standard deviation (RSD). Based on the comparison of the two HPLC methods, the cefadroxil method was recommended to replace the TLC method, which has been prescribed by the EP as the official method for determination of extraneous impurities in cefradine.

Keywords

References

  1. Emaldi, P.; Fapanni, S.; Baldini, A. J. Chromatogr. A 1995, 711, 339 https://doi.org/10.1016/0021-9673(95)00520-W
  2. Yongxin, Z.; Hendrix, C.; Busson, R.; Janssen, G.; Roets, E.; Hoogmartens, J. J. Pharm. Biomed. Anal. 1994, 12, 1137 https://doi.org/10.1016/0731-7085(94)00042-5
  3. Hendrix, C.; Yongxin, Z.; Pijcke, M.; Roets, E.; Hoogmartens, J. J. Pharm. Biomed. Anal. 1993, 11, 595 https://doi.org/10.1016/0731-7085(93)80010-X
  4. Crombez, E.; Bens, G. A.; Van der Weken, G.; Van den Bossche, W.; De Moerloose, P. Chromatographia 1978, 11, 6
  5. White, E.; Roderick, J.; Zarembo, E. J. Antibiotics 1981, 34, 836 https://doi.org/10.7164/antibiotics.34.836
  6. Moore, C. M.; Sato, K.; Katsumata, Y. J. Chromatogr. B 1991, 539, 215 https://doi.org/10.1016/S0021-9673(01)95377-4
  7. Morsch, L. M.; Bittencourt, J.; Souza, M. J. Pharm. Biomed. Anal. 2002, 30, 643 https://doi.org/10.1016/S0731-7085(02)00343-6
  8. Yun, E. K.; Prince, A. J.; McMillin, J. E.; Welch, E. J. Chromatogr. B 1998, 712, 145 https://doi.org/10.1016/S0378-4347(98)00170-4
  9. Farag, S. A. J. AOAC. Int. 1998, 81, 381
  10. Ting, S. J. Assoc Off Anal. Chem. 1998, 71, 1123
  11. Nishino, I.; Fujitomo, H.; Umeda, T. J. Chromatogr. B 2000, 749, 101 https://doi.org/10.1016/S0378-4347(00)00381-9
  12. Bafeltowska, J. J.; Buszman, E.; Mandat, K.; Hawranek, J. J. Chromatogr. A 2002, 976, 249 https://doi.org/10.1016/S0021-9673(02)01234-7
  13. Gallo Martinez, L.; Campins Falco, P.; Sevillano, A.; Cabeza, A. J. Pharm. Biomed. Anal. 2002, 29, 405 https://doi.org/10.1016/S0731-7085(02)00089-4
  14. Johnson, V. M.; Allanson, J. P.; Causon, R. C. J. Chromatogr. B 2000, 740, 71 https://doi.org/10.1016/S0378-4347(00)00023-2
  15. Guitton, J.; Laffont, A.; Rochet-Mingret, L.; Bonnefoy, M.; Bureau, J. J. Chromatogr. B 1998, 719, 151 https://doi.org/10.1016/S0378-4347(98)00333-8
  16. Nee Ling, S. S.; Yuen, K. H.; Barker, S. A. J. Chromatogr. B 2003, 783, 297 https://doi.org/10.1016/S1570-0232(02)00657-8
  17. Hanko, V. P.; LaCourse, W. R.; Dasenbrock, C. O.; Rohrer, J. S. Drug Development Research 2001, 53, 268 https://doi.org/10.1002/ddr.1196
  18. Monograph Cefradine in European Pharmacopoeia, 5th ed.; Suppl. 5.0, European Directorate for Quality of Medicines: Strasbourg, France, 2005
  19. Monograph Cephradine in United States Pharmacopoeia/National Formulary; United State Pharmacopoeial Convention, 24th ed.; United States Pharmacopoeia/National Formulary: Rockville, MD, 2000
  20. Mou, S.; Ding, X.; Liu, Y. J. Chromatogr. B 2002, 781, 251 https://doi.org/10.1016/S1570-0232(02)00619-0
  21. Ahuja, S. S. Advanced Drug Delivery Reviews 2007, 59, 3 https://doi.org/10.1016/j.addr.2006.10.003
  22. Nageswara Rao, R.; Nagaraju, V. J. Pharm. Biomed. Anal. 2003, 33, 335 https://doi.org/10.1016/S0731-7085(03)00293-0
  23. Monograph Cefadroxil Monohydrate in European Pharmacopoeia, 5th ed.; Suppl. 5.0, European Directorate for Quality of Medicines: Strasbourg, France, 2005

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