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

• A novel stability-indicating RP-HPLC method has been developed for a topical cream preparation.
• Simultaneous quantitation of betamethasone-17-valerate, fusidic acid, potassium sorbate, methylparaben and propylparaben.
• Validation has been performed according to current ICH guidelines.
• The method has been employed during formulation development and stability studies.

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.

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