酸性染料比色法测定盐酸美金刚片的含量及溶出度

Determination of Content and Dissolution of Memantine Hydrochloride Tablets by Acid Dye Colorimetry

目的测定盐酸美金刚片的含量和溶出度。方法采用溶剂萃取酸性染料比色法测定含量,检测波长为412nm;溶出度以桨法测定,转速为75r/min,溶出介质为100mL醋酸-醋酸钠缓冲液(pH=4.5)。结果盐酸美金刚质量浓度在2.024～10.12μg/mL范围内与吸光度线性关系良好,r=0.9999(n=5);平均回收率为100.3%,RSD=0.3%(n=9)。片剂于45min取样,主药溶出80%以上。结论所用方法简便、准确,专属性强,可作为盐酸美金刚片的含量测定和质量控制方法 。

Objective To determine the content,uniformity and dissolution of Memantine Hydrochloride Tablets.Methods The solvent extraction acid dye colorimetry method was used with the detection wavelength at 412 nm.The paddle method was used to determine the dissolution.The rotation speed was 75 r /min and the dissolution medium was 100 mL of acetic acid-sodium acetate buffer solution（pH = 4.5）.Results The linear range of the standard curve was 2.024-10.12 μg /mL（r = 0.999 9,n = 5）.The average recovery rate was 100.3% with RSD = 0.3%（n = 9）.The drug dissolution at 45 min was above 80%.Conclusion This method is simple,convenient,accurate and specific for the content determination and quality control Memantine Hydrochloride Tablets.