European Journal of Biomedical and Pharmaceutical Sciences

BIO-ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF DULOXETINE HYDROCHLORIDE BY USING RP-UFLC METHOD

N. G. Rashmi*, Hanumanthachar Joshi and B. M. Gurupadayya

ABSTRACT

The present research method relates to the bio-analytical method development and validation of reversed-phase ultrafast liquid chromatography (RP-UFLC) using LC-Solutions software with an auto sampler. The estimation of duloxetine hydrochloride drug in human blood plasma: Duloxetine hydrochloride (DLX), an anti-depressant drug. Separation of DLX was performed on Phenomenex C18 (250 x 4.6, 5μm particle size) column. Ambient temperature was maintained. Mobile phase consists of a mixture of acetonitrile and 0.01N potassium dihydrogen orthophosphate (55:45). Injection volume of 10 μl was used. Mobile phase was filtered before use through 0. 45 μm membrane filter. Components of the mobile phase were pumped from the solvent reservoir to the column at flow rate 1 ml/min and detector wavelength was set to 215nm. Excellent linearity was observed for DLX (r2 = 0.9996; concentration range 200–1000 ng/ml) The LODs and LOQs for DLX was 100 ng/ml and 200 ng/ml, respectively.

Keywords: Anti-depressant drugs, Duloxetine hydrochloride, RP-UFLC, Pharmaceutical formulation.