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Development and validation of stability-indicating HPLC method for betamethoasone dipropionate and related substances in topical formulation

Author(s): AS Vairale, P Sivaswaroop, S Bandana

A gradient reversed phase HPLC method was developed and validated for analysis of betamethasone dipropionate, its related substances and degradation products, using Altima C18 column (250×4.6 mm, 5 µm) with a flow rate of 1.0 ml/min and detection wavelength of 240 nm. The mobile phase A is a mixture of water, tetrahydrofuran and acetonitrile in the ratio of 90:4:6 (v/v/v) while mobile phase B is a mixture of acetonitrile, tetrahydrofuran, water and methanol in the ratio of 74:2:4:20 (v/v/v/v). The samples were analyzed using 20 µl injection volume and the column temperature was maintained at 50°. The limit of detection and limit of quantitation were found to be 0.02 µg/ml and 0.07 μg/ml, respectively. The stability-indicating capability of method was established by forced degradation studies and method demonstrated successful separation of drug, its related substances and degradation products. The method was validated as per the International Conference on Harmonization guidelines. The developed method is linear in the range of 0.07 to 200% of specification limits established for all the known related substances; betamethasone17â??propionate, betamethasone 21â??propionate, betamethasone 17â??propionateâ??21â??acetate (RSD <5, 2, 1%, respectively, r2=09991â??0.9999 for sample concentration of 100 µg/ml). The method is sensitive, specific, linear, accurate, precise and stability indicating for the quantitation of drug, its related substances and other degradation compounds.

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