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Development and Validation of UPLC Method for the Determination of Duloxetine Hydrochloride and Its Impurities in Active Pharmaceutical Ingredient
A suitable, rapid, sensitive and accurate ultra-performance liquid chromatography (UPLC) method was developed for the quantitative determination of Duloxetine hydrochloride and its impurities in active pharmaceutical ingredient. Chromatographic separation was achieved on shim-pack XR-ODS II (3.0 × 100 mm, 2.2 μm), and the gradient eluted within a period of time, that is, 15 minutes. The eluted compounds were monitored at 230 nm. The flow rate was 0.9 ml/min and the column oven temperature was maintained at 40ºC.
Citation: Rohith T, Ananda S, Sajan PG, Gowda NM (2015) Development and Validation of UPLC Method for the Determination of Duloxetine Hydrochloride and Its Impurities in Active Pharmaceutical Ingredient. J Anal Bioanal Tech 6:234. doi: 10.4172/2155-9872.1000234
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