Stress degradation studies on Iloperidone and development of a stabilityindicating HPLC method for bulk drug and pharmaceutical dosage form

A very sensitive stability indicating RP-HPLC method has been developed and validated for iloperidone in the presence of its degradation products generated in studies of stressed decomposition. Iloperidone is recently approved and marketed in US for the treatment of psychosis. This method is based on HPLC determination of iloperidone by using C-18 column (250 mm × 4.6 mm, 5.0 μ) with isocratic conditions and simple mobile phase containing acetonitrile: 0.025M KH2PO4: triethylamine (60:39.9:0.1) at flow rate of 1 mL/min using UV detection at 229 nm. This method has been applied to formulation without interference of excipients of formulation and was validated with respect to linearity, precision, accuracy, and selectivity. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 100-600 ng/mL. The mean values of the correlation coefficient, slope and intercept were 0.9987, 0.00047 and 5.789149, respectively for iloperidone. The limit of detection (LOD) and limit of quantitation (LOQ) was 30 ng/mL and 60 ng/ml respectively. Statistical analysis showed that the method is repeatable and selective for the estimation of iloperidone as the bulk drug and in pharmaceutical preparations. The drug substances were subjected to stress by acid and base hydrolysis (0.1 N HCl and 1 N NaOH), oxidation (6% H2O2), neutral degradation, photolysis, and dry heat degradation studies (80°C). The drug was degraded under acidic, basic and oxidative conditions but was stable under other stress conditions investigated. Because the method effectively separates the drug from its degradation products, it can be used as stability-indicating

Author(s): Leenata P. Mandpe and Varsha B. Pokharkar

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