Determination of Content and Related Substances of Lomerizine Hydrochloride in Capsule by HPLC

OBJECTIVE To establish a method to determine the content and related substances of lomerizine hydrochloride capsule. METHODS HPLC was adopted on a Diamonsil-ODS column (250 mm×4.6 mm, 5 μm) using an isocratic mobile phase consisted of acetonitrile-0.001 mol·L^-1 SDS (60∶40) with a flow rate of 1.0 mL·min^-1. The column temperature was kept at 35 ℃ and the detection wavelength was set at 225 nm. RESULTS Lomerizine hydrochloride and its related impurities could be separated effectively. The concentration-response relationship was linear over the range of 17.04-153.40 mg·mL^-1(r=1.000). The average recovery was 99.8%(RSD=1.12%, n=9). The solution was stable for 24 h. CONCLUSION The method is specific, accurate, sensitive and suitable for the determination of content and related substances of lomerizine hydrochloride.