关键词: 乙酰乌头碱片, UPLC, 含量测定, 溶出度测定, 溶出度曲线

Abstract: Objective： To establish an ultra performance liquid chromatography (UPLC) method for determination of the content and dissolution of acetylaconitine tablets. Methods：The chromatographic separation was performed on Waters BEH C18 column (2.1 mm×100 mm，1.7μm)，and the mobile phase was 0.01 mol·L-1 sodium heptanesulfonate-acetonitrile (60∶40). The flow rate was 0.6 mL·min-1， and the detection wavelength was 232 nm. The sample size was 10 μL. Dissolution test was performed using cylinder and small cup method， The pH 1.2 hydrochloric acid solution， pH 2.1 hydrochloric acid solution， pH 4.5 acetate buffer solution， pH 6.8 phosphate buffer and purified water were used as dissolution media under stirring rate of 50 r·min-1 and 75 r·min-1. The dissolution curve was drawn by UPLC method and the dissolution conditions were determined. Results： The specificity of the UPLC method established was good. The acetylaconitine tables linear relationship was good in the range of 0.75-6.00 μg·mL-1， and the linear regression equation was Y=57 324X-1273(r2=0.999 9). The average recovery was 98.16% (RSD=0.39%， n=9). The dissolution conditions established was that l00 mL hydrochloric acid solution (pH 2.1) as the dissolution medium， stirring rate 75 r·min-1， and the dissolution time 60 min. The dissolution rates of 4 batches of acetylaconitine tablets from 2 manufacturers were all over 85%. Conclusion： The dissolution conditions were suitable for the dissolution determination of acetylaconitine tablets. The method established for content and dissolution determination is reliable and accurate， with high precision， good reproducibility and feasibility and suitable to be used for the content determination and dissolution analysis of acetylaconitine tablets.

Key words: Acetylaconitine tablets, UPLC, Content determination, Dissolution determination, Dissolution curve