Content Determination of Main Component and Related Substances in Amlodipine Maleate Dispersible Tablets by HPLC

OBJECTIVE: To established an HPLC method for the determination of main component and related substances in amlodipine maleate dispersible tablets. METHODS: The separation was performed on a Lichrospher C18 column. The mobile phase consisted of methanol-0.03 mol?L-1 potassium dihydrogen phosphate (70 ∶ 30) at the flow rate of 1 mL·min-1. The detection wavelength was set at 237 nm and column temperature was 30 ℃. RESULTS: The linear range of amlodipine maleate were 31.94～127.75 μg·mL-1 (r=0.999 8, n=5). The average recovery was 99.5% (RSD=0.39%, n=9). The contents of related substance were all lower than 0.38%. CONCLUSION: The method is simple, rapid, accurate and specific for the quality control of amlodipine maleate dispersible tablets.