Article Detail

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

Article Contents

    Development of alternative titration method without mercuric acetate for the assay of difemerine hydrochloride in Korean Pharmaceutical Codex

    Analytical Science and Technology / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
    2014, v.27 no.4, pp.196-200
    https://doi.org/10.5806/AST.2014.27.4.196


    • Downloaded
    • Viewed

    Abstract

    Currently nonaqueous titration method for the assay method using the hazardous reagent, mercuryacetate for difemerine hydrochloride has been used in Korean Pharmaceutical Codex. We developed analternative titration assay method by substituting the use of the hazardous reagent, mercury acetate to the useof less toxic ones like ethyl alcohol. The linearity of the calibration curves in the desired concentration rangewas good (r>0.999). Precision was less than 0.64%. Accuracy was obtained with recoveries in range of 99.10%and 99.71%. The developed assay could be expected to become valuable tools for revising the KoreanPharmaceutical Codex.

    keywords
    Korean Pharmaceutical Codex, hazardous reagents, alternative testing methods, validation, titration


    Reference

    1

    1. ICH Guideline. Q3C(R4) : Impurities : Guideline for residual solvents Q3C(R4) in ICH harmonised tripartite guideline (2009).

    2

    2. K. Alfonsi, J. Colberg, P. J. Dunn, T. Fevig, S. Jennings, T. A. Johnson, H. P. Kleine, C. Knight, M. A. Nagy, D. A. Perry and M. Stefaniak, Green Chem., 10, 31-36(2008).

    3

    3. Ministry of Food and Drug Safety, 11-1470000-002440-01, 56, 2, Republic of Korea (2011).

    4

    4. Ministry of Food and Drug Safety No. 2012-142, Republic of Korea (2012).

    5

    5. Ministry of Food and Drug Safety, No. 2012-129, 1368, Republic of Korea (2012).

    6

    6. S. Budauari, Merck index 13th ed., Merck & Co., Inc (2001).

    7

    7. Difemerine HCl, http://www.health.kr/drug_info/basedrug/list.asp, Assessed 18 Jul (2014).

    8

    8. JEF. Reynolds, Martindale the extra pharmacopoeia 13th Ed., Pharmaceutical press (1993).

    9

    9. Ministry of Food and Drug Safety No. 2009-173, Republic of Korea (2009).

    10

    10. Ministry of Food and Drug Safety No. C0-2012-2-005, Republic of Korea (2012).

    상단으로 이동

    Analytical Science and Technology