Abstract: Objective To separate and determine the content of sotalol hydrochloride by HPLC. Methods A CHIRALPAK AD-H chiral phase column (5 μm, 250 mm×4.6 mm) was used, with a mobile phase of n-hexane-ethanol (80∶20), at the flow rate of 1.0 mL·min^-1. The detection wavelength was 225 nm, the column temperature 25 ℃, and the injection volume was 10 μL. Results The two enantiomers were well separated, and the resolution between the peaks of the two enantiomers exceeded 2.0. The linearity between the two enantiomers was good within the range of 1.005~100.5 μg·mL^-1 (r=0.999) and 1.073~107.3 μg·mL^-1 (r=0.999), respectively. The average recovery of the two enantiomers was 97.05% and 98.24% respectively, with an RSD of 2.26% and 2.80%, respectively. The detection limit of the two enantiomers was 0.1 μg·mL^-1, and the quantification limit was 0.3 μg·mL^-1. The precision test, repeatability test, and stability test proceeded well. Conclusion The established method is accurate and reliable, which can be used in chiral separation and content determination of sotalol hydrochloride.

Key words: sotalol hydrochloride, enantiomer, HPLC, chiral separation, content determination