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    Development and validation of a novel stability-indicating HPLC method for the simultaneous assay of betamethasone-17-valerate, fusidic acid, potassium sorbate, methylparaben and propylparaben in a topical cream preparation


    Byrne, Jonathan and Velasco-Torrijos, Trinidad and Reinhardt, Robert (2014) Development and validation of a novel stability-indicating HPLC method for the simultaneous assay of betamethasone-17-valerate, fusidic acid, potassium sorbate, methylparaben and propylparaben in a topical cream preparation. Journal of Pharmaceutical and Biomedical Analysis, 96. pp. 111-117. ISSN 1873-264X

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    Abstract

    A novel stability-indicating reversed phase high performance liquid chromatographic (RP-HPLC) method for the simultaneous assay of betamethasone-17-valerate, fusidic acid and potassium sorbate as well as methyl- and propylparaben in a topical cream preparation has been developed. A 100 mm × 3.0 mm ID. Ascentis Express C18 column maintained at 30 °C and UV detection at 240 nm were used. A gradient programme was employed at a flow-rate of 0.75 ml/min. Mobile phase A comprised of an 83:17 (v/v) mixture of acetonitrile and methanol and mobile phase B of a 10 g/l solution of 85% phosphoric acid in purified water. The method has been validated according to current International Conference on Harmonisation (ICH) guidelines and applied during formulation development and stability studies. The procedure has been shown to be stability-indicating for the topical cream.

    Item Type: Article
    Keywords: HPLC; Fusidic acid; Betamethasone-17-valerate; Preservatives; Development; Validation;
    Academic Unit: Faculty of Science and Engineering > Chemistry
    Item ID: 10741
    Identification Number: https://doi.org/10.1016/j.jpba.2014.03.005
    Depositing User: Dr. Trinidad Velasco-Torrijos
    Date Deposited: 23 Apr 2019 14:29
    Journal or Publication Title: Journal of Pharmaceutical and Biomedical Analysis
    Publisher: Elsevier
    Refereed: Yes
    URI:

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