A stability-indicating hplc assay with on-line clean-up for betamethasone 17-valerate in topical dosage forms

Smith, E.W. and Haigh, J.M. and Kanfer, I. (1985) A stability-indicating hplc assay with on-line clean-up for betamethasone 17-valerate in topical dosage forms. International Journal of Pharmaceutics, 27 (2/3). pp. 185-192. ISSN 0378-5173

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Official URL: http://dx.doi.org/10.1016/0378-5173(85)90068-7

Abstract

A stability-indicating high-performance liquid chromatographic method with on-line clean-up has been developed for the analysis of betamethasone 17-valerate in topical dosage forms. A short pre-column containing 10 μm octadecylsilane mounted into the sample loop position of an injection valve was used as the primary clean-up step. The utilization of a diode-array UV detector allowed the quantitative analysis of betamethasone 17-valerate together with its degradation product, betamethasone 21-valerate, as well as the qualitative analysis of these compounds, relevant internal standards and the preservatives chlorocresol and methyl hydroxybenzoate contained in the cream and lotion formulations, respectively. Typically, cream and lotion dosage forms were dissolved in acetonitrile and ointments in tetrahydrofuran, internal standards added and aliquots injected onto the analytical system. Dosage form excipients were retained on the loop column and back-flushed to waste with the aid of a second solvent pump while components of interest were allowed to transfer to the analytical column for quantitative analysis. The method is accurate, precise and stability indicating and permits the rapid on-line analysis of betamethasone 17-valerate from complex topical formulation matrices without prior extractions.

Item Type:Article
Uncontrolled Keywords:HPLC; betamethasone 17-valerate; betamethasone 21-valerate; stability-indicating; cream; lotion; ointment; on-line clean-up; drug dosage form; drug formulation; high performance liquid chromatography; betamethasone; betamethasone valerate; drug determination; drug dosage form; drug formulation; drug stability; high performance liquid chromatography; ultraviolet spectrophotometry
Subjects:Y Unknown > Subjects to be assigned
Divisions:Faculty > Faculty of Pharmacy
ID Code:395
Deposited By: Prof John Haigh
Deposited On:31 May 2007
Last Modified:06 Jan 2012 16:18
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