Abstract:

We developed a chiral HPLC method for the separation and analysis of naftopidil enantiomers. The two enantiomers of naftopidil were separated using a Chiralpak AD-H (250 mm×4.6 mm, 5 μm) column and monitored at the wavelength of 283 nm. The isocratic mobile phase consisting of hexane–isopropanol–diethylamine (85:15:0.1, v/v/v) was pumped at a flow rate of 1.0 mL/min. Under these chromatographic conditions, R-naftopidil and S-naftopidil were well separated and had good linearity in the ranges of 0.78–50 μg/mL (r = 0.9999) and 0.84–54 μg/mL (r = 0.9998), respectively. The relative standard deviations (RSD) of intra- and inter-day assays were no more than 0.5% and 0.7%, respectively. This improved method for the separation and quantitative determination of naftopidil enantiomers can be used for the quality control of synthesized naftopidil product.

Key words: Enantiomers, Enantiomers, Naftopidil, Naftopidil, Chiral HPLC, Chiral HPLC, Analysis, Analysis