Validated Stability-Indicating High-performance liquid chromatographic method for determination of Duloxetine Hydrochloride in bulk drug and dosage form

A rapid, sensitive reversed phase stability-indicating high-performance liquid chromatographic (HPLC) assay method was developed and validated for quantitative determination of duloxetine hydrochloride in bulk drugs and the degradation products generated from forced decomposition. A gradient, reversed phase HPLC method was developed to separate the drug from the degradation products, using an Kromasil C18 (250mm x 4.6) mm, 5u column and the mixture of 0.1% Orthophosphoric acid and acetonitrile was used as mobile phase. The detection was carried out at wavelength 230 nm. The chromatographic resolution between its degraded products was found to be greeter than three. The duloxetine hydrochloride was subjected to stress conditions of hydrolysis acid, base, oxidation (30 % H2O2), and thermal degradation. The degradation was observed for duloxetine hydrochloride in base and in thermal hydrolysis. The mass balance was close to 100 in all the stress conditions. The degraded products were well resolved from main peak. The developed method was validated with respect to linearity, accuracy, recovery, precision, system suitability, selectivity, robustness and forced degradation studies prove the stability indicating ability of the method.