高效液相色谱法测定萘丁美酮分散片的溶出度

Determination of Dissolution of Nabumetone Dispersible Tablets by HPLC

目的建立测定萘丁美酮分散片溶出度的高效液相色谱(HPLC)法。方法以0.5%十二烷基硫酸钠溶液为溶出介质,转速为50r/min,取样时间为45min,采用桨法测定萘丁美酮分散片的溶出度。结果萘丁美酮检测质量浓度的线性范围为20～100μg/mL(r=0.9999),平均回收率为99.56%,RSD=1.13%(n=9),3批样品45min平均溶出度均在90%以上。结论该方法操作简便,结果准确可靠。

Objective To establish a HPLC method for the dissolution determination of Nabumetone Dispersible Tablets. Methods 0. 5% SDS was taken as the solvent with the rotating speed at 50 r/min, and the sampling time was 45 min. The dissolution of Nabumetone Dispersible Tablets was determined by oar method. Results The linear range of nabumetonc was 20- 100 μg/mL（r=0. 999 9）, with the average recovery rate at 99.56% （RSD = 1.13% ）. The mean cumulative dissolutions of three batches of Nabumetone Dispersible Tablets were above 90%. Conclusion The established method is simple, accurate and reliable.