• P-ISSN1225-0163
  • E-ISSN2288-8985
  • SCOPUS, ESCI, KCI

Article Detail

Home > Article Detail
  • P-ISSN 1225-0163
  • E-ISSN 2288-8985

Monitoring of preservatives in herbal liquid preparations

Analytical Science and Technology / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
2011, v.24 no.2, pp.127-134
https://doi.org/10.5806/AST.2011.24.2.127








  • Downloaded
  • Viewed

Abstract

Quantitative HPLC analysis for the determination of in herbal liquid preparations was improved from the general test method besides the Korean Pharmacopeia. Good chromatographic separation of samples containing parabens, interferences, and other pharmaceutical excipients was effectively achieved by using acetonitrile · water (containing 1% glacial acetic acid) mixture (30:70 v/v) as mobile phase. To monitor preservatives (benzoic acid, parabens, sorbic acid, dehydroacetic acid, and their salts) in herbal liquid preparations, a group of 47 samples was divided into two different group: preservative labeled group and unlabeled group. From the results, the contents of preservatives in 31 samples of preservative labeled group fell under KFDA regulations, and the contents of dehydroacetic acid in 6 samples of preservative labeled group were not followed by KFDA regulations. Preservatives were detected in 3 samples out of 10 samples in preservative unlabeled group.

keywords
herbal liquid preparations, pharmaceutical excipients, preservatives


Reference

1

1. Korea Food and Drug Administration, Korean Pharmacopoeia, Ninth Edition (2007).

2

2. Baldrick, P., Regul. Tox. Pharm., 32, 210-218(2000).

3

3. European Medicine agency, Guideline On Excipients In The Dossier For Application For Marketing Authorisation Of A Medicinal Product, Available from http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003382.pdf. Accessed Dec. 02(2010).

4

4. Korea Food and Drug Administration, Notice No. 2010-71 (2010).

5

5. Korea Food and Drug Administration, Notice No. 2010-82 (2010).

6

6. Shabir, G. A., J. Pharm. Biomed. Anal., 34, 207-213(2004).

7

7. Memon, N., Bhanger, M. I. and Khuhawer, M. Y., J. Sep. Sci., 28, 635-638(2005).

8

8. Mikami, E., Goto, T., Ohno, T., Matsumoto, H. and Nishida. M., J. Pharm. Biomed. Anal., 28, 261-267 (2002).

9

9. Lee, M. R., Lin, C. Y., Li, Z. G. and Tsai, T. F., J. Chromatogr A., 1120, 244-51(2006).

10

10. Korea Food and Drug Administration, Notice No. 2008-76 (2008).

11

11. FDA CEDER. Validation of chromatographic methods, Available from http://www.fda.gov/downloads/Drugs/Guidance Compliance RegulatoryInformation/Guidances/UCM134409.pdf, Accessed Dec. 02 (2010).

12

12. USDA. Determination of Benzoic acid, Sorbic aicd, and Methyl, Ethyl, Propyl, and Butyl Parabens by HPLC, Available from http://www.fsis.usda.gov/PDF/CLG_BSP_01.pdf, Accessed Dec. 02 (2010).

13

13. Chen, B. H. and Fu, S. C., Chromatographia, 14, No. 1/2, 43-50(1995).

14

14. Memon, N., Bhanger, M.I. and Khuhawer, M.Y., J. Sep. Sci., 28, 635-638(2005).

15

15. Ochiai, N., Sasamoto, K., Takino, M., Yamashita, S., Daishima, S., Heiden, A. C. and Hoffmann, A., Anal Bioanal Chem, 373, 56-63(2002).

16

16. Li, XQ., Ji, C., Yong, W., Ling, Y., Yang, M. L. and Chu, X. G., Chromatographia, 68, 57-63(2008).

17

17. Korea Food and Drug Administration, Korean Food Code (2010).

18

18. Korea Food and Drug Administration, Optimization Plan of Use Standard for Preservatives, The annual report of KFDA (2009).

19

19. WHO, Benzoic acid and sodium benzoate. Concise International Chemical Assessment Document 26. World Health Organization, Geneva, Switzerland (2000).

20

20. Soni, M. G., Carabin, I. G. and Burdock, G. A., 43, 985-1015(2005).

21

21. Oishi, S., Food Chem. Toxicol., 40, 1807-1813(2002).

22

22. Routledge, E. J., Rarker, J., Odum, J., Ashby, J. and Sumpter, J. P., Toxicol. Appl. Pharmacol., 153, 12-19 (1998).

23

23. Jeong, I. H., Kim, J. H., Jeon, J. S., Cho, S. H., Par, S. H., Jo, H. Y. and Kim, Y. S., J. Fd Hyg. Safety, 25(3), 232-237(2010).

24

24. Korea Food and Drug Administration, Notice No. 2010-103 (2010).

25

25. Kim, M. C., Park, H. K., Hong, J. H., Lee, D. Y., Park, J. S., Park, E. J., Kim, J. W., Song, K. H., Shin, D. W., Mok, J. M., Lee, J. Y. and Song, I. S., Korean J. Food. Sci. Technol., 31(5), 1144-1152(1999).

26

26. Lee, H. J., Ahn, H. J., Kang, C. S., Choi, J. C., Choi, J. C., Lee, K. G., Kim, J. I. and Kim, H. Y., Food Control, 21, 217-220(2010).

상단으로 이동

Analytical Science and Technology