분석과학 (Analytical Science and Technology)

  • 제30권3호
  • /
  • Pages.154-158
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  • 2017
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  • 1225-0163(pISSN)
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  • 2288-8985(eISSN)
한국분석과학회 (The Korean Society of Analytical Sciences)
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Development of HPLC assay method of fusidate sodium tablets

  • Lee, GaJin (College of Pharmacy, Kangwon National University) ;
  • Choi, Min (College of Pharmacy, Kangwon National University) ;
  • Truong, Quoc-Ky (College of Pharmacy, Kangwon National University) ;
  • Mai, Xuan-Lan (College of Pharmacy, Kangwon National University) ;
  • Kang, Jong-Seong (College of Pharmacy, Chungnam National University) ;
  • Woo, Mi Hee (College of Pharmacy, Catholic University of Daegu) ;
  • Na, Dong-Hee (College of Pharmacy, Chungang University) ;
  • Chun, In-Koo (The Society of Korean Official Compendium for Public Health) ;
  • Kim, Kyeong Ho (College of Pharmacy, Kangwon National University)
  • 투고 : 2017.05.10
  • 심사 : 2017.06.14
  • 발행 : 2017.06.25
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초록

The Korean Pharmacopoeia (KP XI), British Pharmacopoeia (BP 2013) and Japanese Pharmacopoeia contain monographs for the quality control of raw fusidate sodium and its formulations using high performance liquid chromatography (HPLC). However, the assay method for the determination of fusidate sodium in commercial tablets is titration which is less specific than HPLC. In this study, we present an alternative HPLC method for quantitation of fusidate sodium in tablets. Method validation was performed to determine linearity, precision, accuracy, system suitability, and robustness. The linearity of calibration curves in the desired concentration range was high ($r^2=0.9999$), while the RSDs for intra- and inter-day precision were 0.25-0.37 % and 0.11-0.60 %, respectively. Accuracies ranged from 99.46-100.85 %. Since the system suitability, intermediate-precision and robustness of the assay were satisfactory, this method will be a valuable addition to the Korean Pharmacopoeia (KP XI).

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참고문헌

  1. Merck Research Laboratories, The Merck Index, 14th Ed., United States (2006).
  2. A. H. Hikal, A. Shibl, and S. El-Hoofy, J. Pharm. Sci., 71(11), 1297-1298 (1982). https://doi.org/10.1002/jps.2600711130
  3. The Ministry of Health, Labour and Welfare, The Japanese Pharmacopoeia, 17th Ed., Japan (2016).
  4. Ministry of Food and Drug Safety, The Korean Pharmacopoeia, 11th Ed., Republic of Korea (2014).
  5. Medicines & Healthcare Products Regulatory Agency, British Pharmacopoeia, 7th Ed., United Kingdom (2013).
  6. The United States Pharmacopeial Convention, The United States Pharmacopeia, USP 39 NF 34, United States (2016).
  7. J. Byrne, T. Velasco-Torrijos, and R. Reinhardt, J. Pharm. Biomed. Anal., 96, 111-117 (2014). https://doi.org/10.1016/j.jpba.2014.03.005
  8. S. Shaikh, M.S. Muneera, O.A Thusleem, M. Tahir, and A. V. Kondaguli, J. Chromato. Sci., 47, 178-183 (2009). https://doi.org/10.1093/chromsci/47.2.178
  9. M. Nawaz, M. S. Arayne, N. Sultana, A. Haider, and S. Hisaindee, Acta Chromatogr., 26, 57-66 (2014). https://doi.org/10.1556/AChrom.26.2014.1.6
  10. J. Byrne, T. Velasco-Torrijos, and R. Reinhardt, J. Chromato. Sci., 53, 1498-1503 (2015). https://doi.org/10.1093/chromsci/bmv045
  11. H. Sorensen, J. Chromatography, 430, 400-408 (1988). https://doi.org/10.1016/S0378-4347(00)83177-1
  12. R. Leclercq, R. Bismuth, I. Casin, J. D. Cavallo, J. Croize, A. Felten, F. Goldstein, H. Monteil, C. Quentin-Noury, M. Reverdy, M. Vergnaud, and R. Roiron, J. Antimicrob. Chemother., 45(1), 27-29 (2000). https://doi.org/10.1093/jac/45.1.27
  13. ICH Guideline. Q2(R1): validation of Analytical Procedures: Text and Methodology Q2(R1) in ICH Harmonised Tripartite Guideline (2005).
  14. Ministry of Food and Drug Safety No. 2009-173 (2009. 12. 15), Republic of Korea.
  15. Ministry of Food and Drug Safety, No. C0-2012-2-005 (2012. 09. 19), Republic of Korea.