, Volume 48, Issue 11–12, pp 797–802

Development and validation of stability indicating high-performance liquid chromatographic assays for ketotifen in aqueous and silicon oil formulations

  • I. P. Nnane
  • L. A. Damani
  • A. J. Hutt


A simple and specific high-performance liquid chromatographic (HPLC) method for the analysis of ketotifen in aqueous solutions and silicon oil suspensions is described. The HPLC system is based on a reversed phase μBondapak C18 (30×0.39 cm) column with a mobile phase of phosphate buffer (0.001 M, pH 7.4):methanol: acetonitrile: trimethylamine (29.8:45:25:0.2, by volume) at a flow-rate of 1 mL min−1. The eluent was monitored by UV absorption at 299 nm. Silicon oil-based samples were extracted with HCl (0.05 M) using imipramine as internal standard. The recovery of ketotifen and imipramine was greater than 80%. The calibration curves for both assays were linear over the ranges examined, yielding correlation coefficients greater than 0.997. The assay was shown to be stability indicating by subjecting solutions of ketotifen in phosphate buffer to heat, oxidative stress and irradiation with ultraviolet light (254 and 369 nm)for up to 8 h. The methodology was also shown to be applicable for the analysis of ketotifen in simple aqueous based formulations, in suspension in silicon oil and for the analysis of samples derived fromin vitro skin transfer experiments.

Key Words

Column liquid chromatography Ketotifen analysis Stability indicating analysis Aqueous and oil-based formulations 


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  1. [1]
    Sandoz Ltd. Ger. Pat., 2, 302, 994 (1972).Google Scholar
  2. [2]
    S. M. Grant, K. L. Gao, A. Fitton, E. M. Sorkin, Drugs40, 412 (1990).Google Scholar
  3. [3]
    C. Greenwood, Chest82 (Suppl. 1), 45S (1982).Google Scholar
  4. [4]
    M. Eiser, Pharmac. Ther.17, 245 (1982).Google Scholar
  5. [5]
    A. Grahnén, A. Lönnebo, O. Beck, S.-A. Eckernäs, B. Dahlström, B. Lindström, Biopharm. Drug Dispos.13, 255 (1992).Google Scholar
  6. [6]
    T. Fujii, Y. Arai, A. Kubota, K. Togawa, N. Mizushima, I. Mikuni, Hospital Pharmacy (Byoin Yakugaku, Japanese)10, 171 (1984).Google Scholar
  7. [7]
    H. Niizeki, N. Inamoto, K. Nakamura, J. Nakanoma, T. Nakano, Contact Dermatitis31, 266 (1994).CrossRefGoogle Scholar
  8. [8]
    Y. Lee, C. Chiang, J. Chen, Drug Develop. Ind. Pharm.20 2965 (1994).Google Scholar
  9. [9]
    T. G. Franz, J. Invest. Dermatol.64, 190 (1975).CrossRefGoogle Scholar
  10. [10]
    R. L. Bronaugh, R. F. Steward, J. Pharm. Sci.74, 64 (1985).Google Scholar

Copyright information

© Friedr. Vieweg & Sohn Verlagsgesellschaft mbH 1998

Authors and Affiliations

  • I. P. Nnane
    • 1
  • L. A. Damani
    • 2
  • A. J. Hutt
    • 1
  1. 1.Department of PharmacyKing's College LondonLondonUK
  2. 2.Department of Pharmacy, Faculty of MedicineThe Chinese University of Hong KongShatinHong Kong
  3. 3.Department of Pharmacology and Experimental TherapeuticsUniversity of Maryland School of MedicineBaltimoreUSA

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