Xuchang Hengsheng Pharmaceutical Co. Ltd.

The purpose of the research is to establish a method for the dissoly. determination of Manidipine Hydrochloride tablet and to evaluate the quality consistency of generic and original preparationHPLC was performed on the column of Waters Symmetry C₁₈ column with mobile phase of potassium phosphate monobasic solution(potassium phosphate monobasic 6.8 g was well-mixed with water 1000 mL, and pH was adjusted to 4.6 by potassium hydroxide solution)-acetonitrile(49:51, V/V) at flow rate of 1.0 mL/min, detection wavelength was 228 nm, column temperature was 25°C, and the injection volume was 20μL.The dissolution mediums were 0.1 mol/L hydrochloric acid solution, acetic acid-sodium acetate buffer solution(pH 4.0) and phosphate buffer solution[pH 6.8, adding sodium dodecyl sulfonate(SDS)], volume of dissolution medium was 900 mL and rotating rate was 50 r/min, and the dissoly. of Manidipine hydrochloride tablet generic and original preparation was investigated and the similarity of dissolution profile was evaluated by calculating similar factor(f₂).The linear range of manidipine hydrochloride was 0.625-20μg/mL; RSDs of instrument precision and stability tests were lower than 2.0%; recoveries of 3 dissolution mediums were 92.86%-102.97%(RSD=1.9%, 1.8% and 2.7%, n=9), resp.The dissoly. of 3 batches of Manidipine hydrochloride tablet generic and original preparations was higher than 85% in 0.1 mol/L hydrochloric acid solution in 15 min; f₂ was>50 in acetic acid-sodium acetate buffer solution(pH=4.0) and phosphate buffer solution(pH 6.8, adding 0.5% SDS).The method is suitable for the dissoly. determination of Manidipine hydrochloride tablet; meanwhile, the dissolution profile in vitro of Manidipine hydrochloride tablet generic and original preparations has similarities, so the quality consistency is good.