盐酸米帕林片溶出度测定方法研究

Dissolution Test of Mepacrine Hydrochloride Tablets by UV Sepctrophotometry

目的建立紫外分光光度法测定盐酸米帕林片溶出度的方法。方法照2000年版《中国药典(二部)》附录溶出度测定第二法,以盐酸溶液(9→1000)为溶出介质,转速为50r/min,溶出时间60min,紫外分光光度法检测波长425nm。结果盐酸米帕林质量浓度在5.082～50.82μg/mL范围内与吸收度有良好的线性关系,Y=0.0191X+0.0039(r=0.9999),平均回收率为100.2%,RSD=0.33%(n=9)。结论方法简便易行,结果准确。

Objective To establish a UV method for detecting dissolution of mepacrine hydroehloride tablets. Methods Using the dissolution test method in Apparatus Ⅱof Chinese Pharmacopoeia 2000 edition （vol. Ⅱ）, the dissolution medium was hydrochloric acid solution （9→1 000）, the rotating speed was 50 r/min. After 60 min, the dissolution solution was taken and analyzed by UV method at wavelength of 245 nm. Results In the range of 5.082-50.82μg/mL, the linear equation was Y=0. 0191X＋0. 0039（r=0. 9999）.The average recovery rate of mepaerine hydrochloride was 100. 2% with RSD 0. 33%（n = 9）. Conclusion The method is simple, practicable and accurate.