Development of Alternative Assay Method without Hazardous Reagent, Chloroform for Urazamide Tablets in Korean Pharmaceutical Codex

우라자미드 정의 유해시약 대체 시험법의 개발

  • Lee, Yoo Rim (College of Pharmacy, Kangwon National University) ;
  • Kim, Hyun Ji (College of Pharmacy, Kangwon National University) ;
  • Seo, Narae (College of Pharmacy, Kangwon National University) ;
  • Kim, Kyeong Ho (College of Pharmacy, Kangwon National University)
  • Received : 2014.03.04
  • Accepted : 2014.03.28
  • Published : 2014.04.30

Abstract

We developed an alternative assay method without hazardous reagent of chloroform for urazamide tablets in Korean Pharmaceutical Codex. The HPLC analytical method was validated by system suitability, linearity, precision, accuracy and robustness. The linearity of the calibration curves in the desired concentration range is good ($r^2$ >0.999). Precision was obtained less than RSD 1.17%. Accuracy was obtained with recoveries in range of 98.12% and 99.47%. The developed assay could be expected to become valuable tools for revising the Korean Pharmaceutical Codex.

Keywords

References

  1. ICH Guideline. Q3C(R4) : Impurities : Guideline for residual solvents Q3C(R4) in ICH harmonised tripartite guideline (2009).
  2. Alfonsi, K., Colberg, J., Dunn, P. J., Fevig, T., Jennings, S., Johnson, T. A., Kleine, H. P., Knight, C., Nagy, M. A., Perry, D. A. and Stefaniak, M. : Green chemistry tools to influence a medicinal chemistry and research chemistry based organisation. Green Chem. 10, 31 (2008). https://doi.org/10.1039/b711717e
  3. Ministry of Food and Drug Safety, NO. B1-2011-2-031 (2011.01.01).
  4. Ministry of Food and Drug Safety, NO. 2012-142 (2012.03.07).
  5. 이재호, 안광무, 함준수, 이민호, 기춘석 : 만성 간질환 환자에 있어서 Urazamide($Recover^{(R)}$)의 치료효과. 최신의학 30, 89 (1987).
  6. Carminati, G. M. : Pharmacology of 5-amino-4-imidazolcarboxamide ureidosuccinate (CARBAICA), a new gepatotrophic drug. Drug Exptl. Clin. Res. 6, 471 (1980).
  7. Chanoine, F. : Clinical study of AICA orotate in hepatitis and cirrhosis. Acta Gastroenterol Belg. 32, 383 (1969).
  8. Roda, E., Sama, C. and Festi, D. : Controlled clinical evaluation of the therapeutic effectiveness of AICA orotate in chronic hepatitis. Clin. Ter. 89, 489 (1979).
  9. Ministry of Food and Drug Safety NO. 2009-173 (2009.12.15).
  10. Ministry of Food and Drug Safety, NO. C0-2012-2-005 (2012.09.19).