Development and validation of RP-HPLC method for determination of Duloxetine hydrochloride in bulk and dosage form.

ABSTRACT

A reverse phase high performance liquid chromatographic method was developed for the determination of dulox-etine hydrochloride in bulk and dosage form. The separation was effected on a kromasil ODS C18 column (250mmX4.6mm, 5μ) using a mobile phase mixture of buffer and methanol in a ratio of 8515 v/v at a flow rate of 1.0ml/min. The detection was made at 230nm. The retention time of duloxetine hydrochloride was found to be 3.443±0.06 min. Calibration curve was linear over the concentration range of 20-120μg/ml of duloxetine hydrochlo-ride. The propose method was validated as per the ICH guidelines. The method was accurate, precise, specific and rapid found to be suitable for the quantitative analysis of the drug and dosage form.