Abstract

A stability-indicating LC method for the assay estimation of itraconazole in pharmaceutical dosage form

Author(s): Dantu Durga Rao, Shakil S.Sait, P.Sunil Reddy, K.Mukkanti

A stability- indicating HPLC method was developed for the quantitative determination of itraconazole in pharmaceutical dosage forms in the presence of degradation products. It involved aHypersil BDS 100mm4.6mm, 3mC18 column. The separation was achieved on simple isocraticmethod. Themobile phase contains amixture of pH7.5, 20mMK2HPO4buffer: acetonitrile: tetrahydrofuran (50:49:12, v/v/v). The flowrate was 1.2mLmin-1 and the detection wavelength was 225 nm. The retention time of itraconazole is 3.3 min. The total runtime was 4 min within which drug and degradation products were separated. Itraconazole was subjected to different ICH prescribed stress conditions. Degradation was found to occur in oxidative condition, while drugwas stable to hydrolytic, photolytic and thermal stress. The drug was particularly labile under oxidative stress condition. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The method developed was successfully applied to the determination of itraconazole in pharmaceutical preparations. The developed RP-HPLCmethodwas validated with respect to linearity, accuracy, precision and ruggedness.