Abstract
A stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed for the simultaneous determination of halometasone, fusidic acid, methylparaben, and propylparaben in topical pharmaceutical formulation. The desired chromatographic separation was achieved on an Agilent Zorbax CN (Cyano), 5 μm (250 × 4.6 mm) column using gradient elution at 240 nm detector wavelength. The optimized mobile phase consisted of a mixture of 0.01 M phosphate buffer and 0.1% orthophosphoric acid, pH-adjusted to 2.5 with an ammonia solution as solvent-A and acetonitrile as solvent-B. The developed method separated halometasone, fusidic acid, methylparaben, and propylparaben in the presence of known impurities/degradation products. The stability-indicating capability was established by forced degradation experiments and separation of known and unknown degradation products. The developed RP-HPLC method was validated according to the International Conference on Harmonization (ICH) guidelines. This validated method was applied for the simultaneous estimation of HM, FA, MP, and PP in commercially available cream samples. Further, the method can be extended for the estimation of HM, FA, MP, and PP in various commercially available dosage forms.
Highlights
Optimization of chromatographic conditions The primary target in developing this HPLC method was to achieve the simultaneous determination of HM, Fusidic acid (FA), MP, and PP in topical formulation under common chromatographic conditions; this method is applicable for routine quality control of products in pharmaceutical and cosmetic industries
The wavelength was selected by injecting a known concentration of each of HM, FA, MP, and PP into the HPLC with a PDA detector and evaluating the UV spectra of each component
A common wavelength for the simultaneous determination of all components was selected as 240 nm by overlaying the spectra and wavelengths at which all components had significant absorbance
Summary
Corticosteroids act by the induction of lipocortins which prevent the formation of prostaglandins and leukotrienes. Both prostaglandins and leukotrienes are mediators which lead to inflammation. Halometasone acts by blocking their production, acting as an anti-inflammatory agent. It is available as a cream for topical use and used to treat chronic psoriasis vulgaris [1] and non-infected acute eczematous dermatoses [2].
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