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A stability-indicating HPLC assay method for rosiglitazone maleate

M.Lalitha Devi, B.M.Rao, M.B.V.Narayana, K.B.Chandrasekhar

This present paper deals with the development of a stability-indicating high performance liquid chromatographic (LC) method for the quantitative determination of Rosiglitazone maleate. The maleate salt of Rosiglitazone, an orally active thiazolidinedione with antidiabetic properties and potential antineoplastic activity. The chromatographic separation was achieved on a Phenomenex Luna 3 C18 HPLC column using a mobile phase consists of a mixture of sodiumdihydrogen orthophosphate buffer with sodium hexane sulfonate (Solvent A) and organic modifier acetonitrile and methanol (Solvent B). Forced degradation studies were performed on bulk sample of Rosiglitazone maleate using acid(1.0 N hydrochloric acid), base (0.05 N sodiumhydroxide), oxidation (3.0%v/v hydrogen peroxide), thermal (80C) andUVlight (254nm).Degradation of the drug substance was observed in base hydrolysis and oxidation condition. Degradation product formed under base hydrolysis was found to be starting material used during the synthesis of Rosiglitazone maleate. The stressed samples were assayed using the developed LC method and found the mass balance was close to 99.5%, thus proves the stability-indicating power of the developed LC method. The developed LC method was validated with respect to linearity, accuracy, precision and robustness.