拉呋替丁片溶出度测定方法研究

目的 建立拉呋替丁片溶出度的测定方法.方法 溶出方法采用中国药典溶出度第三法,以盐酸溶液(9→1 000)为溶出介质,转速为50 r·min-1,测定方法采用高效液相色谱法,用十八烷基硅烷键合硅胶为填充剂;以甲醇 1%醋酸铵溶液(冰醋酸调节pH值为5.7)(40∶60)为流动相;检测波长为279 nm,进样量 20 μl.结果 拉呋替丁在5～500 mg·L-1内呈良好的线性关系(r=0.999 8),RSD为0.47%(n=6).绘制的溶出曲线表明 30 min内拉呋替丁片可溶出 80%以上,确定的溶出时间为 30 min,限度为 80%.结论 该方法简单快速,准确稳定,可用于拉呋替丁片溶出度.

Determination approach to the dissolution of lafutiding tablets

Objective To establish a test method for the dissolution of Lafutiding tablets.Methods The method of dissolution was the third method of the dissolution test of ChP 2010.The medium was hydrochloric acid solution(9→1 000),and rotation speed was 50 r·min-1.The chromatographic condition of column was Waters SunFire C18(5 μm,4.6 mm × 150 mm) column.The mobile phase consisted of acetonitrile-1% ammonium acetate solution(adjusted to pH 5.7 with glacial acetic acid)(40∶ 60).The wavelength of UV detector was 279 nm,and the injection volume was 20 μl.Results A good linear relationship was obtained when the detection concentration range was between 5 and 500 mg·L-1(r=0.999 8);the RSD of the method was 0.47%(n=6).The curve showed that Lafutiding tablets can dissolve above 80 % within 30 minutes.It is confirmed that the time of dissolution was 30 minutes and the limit was 80%.Conclusion The method is rapid,simple,accurate,and can be used for determining the dissolution of Lafutiding tablets.