RP-HPLC法测定甲磺酸瑞波西汀片的含量及溶出度

目的考察研究甲磺酸瑞波西汀片质量标准中的含量和溶出度。方法采用HPLC法测定甲磺酸瑞波西汀片的含量及溶出度。色谱条件以十八烷基键合硅胶为填充剂;以乙腈-异丙醇-磷酸盐缓冲液（取磷酸氢二铵6.6 g,加水900 ml溶解,加入5 ml三乙胺,用磷酸调节pH值至6.5,加水稀释至1000 ml）（20∶24∶56）为流动相;检测波长为274 nm。溶出度条件以0.1 mol·L-1的盐酸溶液100 ml为溶出介质,转速为50 r·min-1,经30 min取样测定其溶出度。结果甲磺酸瑞波西汀在9.635～385.4μg·ml-1浓度范围内线性关系良好（r=0.9999）,平均回收率为100.16%,RSD为1.22%;3批样品在30 min时的溶出度均超过标示量的80%。结论本方法快速、准确,重复性好,可用于甲磺酸瑞波西汀片的质量标准研究。

Determination of Content and Dissolution of Reboxetine Mesylate Tablets by RP-HPLC

Objective To develop a quality standard for reboxetine mesylate tablets. Methods The content and dissolution of reboxetine mesylate were determined by HPLC. The C18（250 mm ×4.6 mm,5 μm） column was adopted with a mobile phase of acetonitrile-isopropanol-phosphate buffer. The flow rate was 1.0 ml min-1 with column temperature at 30 %. The detection wavelength was set at 274 nm. According to chinese pharmacopoeia 2010 ,the dissolu- tion medium was 0.1 mol L-1 HCl 100 ml and rotating speed was 50 r .min-1 After 30 min the dissolution solution of the tablets was taken and analyzed by HPLC method. Results The linear range was 9.635-385.4 μg .m1-1 （ r =0. 9999）. The average recovery was 100. 16% （ RSD = 1.22%, n = 9）. The results of dissolution of the three batches of samples all meet the requirement. Conclusion An accurate, reliable, and simple method is established that helps determine the con- tent and dissolution of reboxetine mesylate tablets.