Abstract:
A validated reverse phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for the determination of Milnacipran hydrochloride in pharmaceutical preparations. Shimadzu HPLC containing SPD-20Av uv-visible detector, SIL 20 AC HT manual injector, LC-20 AT binary pump with software LC solution of version 1.2 was employed in the present study. Chromatography was carried out on a reverse phase C-18 column (250 x 4.6 mm x 5 µm length); optimum separation was achieved by using a mobile phase containing phosphate buffer (pH 3.6): acetonitrile at a ratio 70:30 with 1 mL/min flow rate and the detection was done at 220 nm. The retention time for Milnacipran hydrochloride was observed at 4.802 min. The method also produced linear responses in the concentration range from 25-75 μg/mL of Milnacipran hydrochloride with correlation coefficients of 0.999, accuracy of 101.3% and precision of 0.70%. As per ICH guideline, this developed method is fast, accurate, precise and sensitive hence it can be employed for routine analysis of Milnacipran hydrochloride in pharmaceutical formulations.

Keywords: Milnacipran, RP-HPLC, Validation, Antidepressant, Neurotransmitter.