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Stability-indicating LC method for the determination of duloxetine hydrochloride in bulk drug and in pharmaceutical dosage form

Amol Waghule, Jaiprakash Sangshetti, Vipul Rane, Kiran Patil, Devanand Shinde

A novel stability-indicating LC assaymethod was developed and validated for quantitative determination of duloxetine in bulk drugs and in pharmaceutical dosage form in the presence of degradation products generated from forced degradation studies. An isocratic, reversed phase LC method was developed to separate the drug from the degradation products, using anAce5-C18 (250mm4.6mm, 5m) column, and 50mMammoniumacetate (pH-5.5 by acetic acid) and acetonitrile (50:50v/v) as a mobile phase. The detection was carried out at the wavelength of 230 nm. The duloxetine was subjected to stress conditions of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. Degradation was observed for duloxetine in all conditions attempted. The degradation products were well resolved from the main peak. The percentage recovery of duloxetine ranged from (99.72 to 100.87%) in pharmaceutical dosage form. The developedmethod was validated with respect to linearity, accuracy (recovery), precision, specificity and robustness. The forced degradation studies prove the stabilityindicating power of the method.