摘要
目的建立盐酸利托君胶囊溶出度的测定方法。方法采用2005年版《中国药典(二部)》附录ⅩC第三法,以盐酸溶液(9→1000)200mL为溶出介质,恒温(37±0.5)℃,采用紫外分光光度法,测定波长275nm。结果转速100r/min、溶出时间45min时,盐酸利托君胶囊的溶出度达标示量的80%以上,以转篮法和桨法测定的溶出度结果无显著性差异,试验均一性良好。结论该方法简单便捷,可作为盐酸利托君胶囊溶出度的测定方法。
Objective To establish the dissolution determination method for Ritodrine Hydroehloride Capsules. Methods According to the third method of Appendix XC in the Chinese Pharmacopeia (edition 2005),200 mL HCI solution(9→1 000) was used as the dissolution solute, kept at (37± 0. 5)℃, and detected by UV spectrophotometry at the wave length of 275 nm. Results The dissolution of Ritodrine Hydroehloride Capsules was above 80% of the calibration amount. There was not any significant difference between the results of rotating basket method and the paddle method, the uniformity of the experiment was quite good. Conclusion This method is simple and easy, which can be used to determine the dissolution of Ritodrine Hydroehloride Capsules.
出处
《中国药业》
CAS
2009年第3期13-14,共2页
China Pharmaceuticals
关键词
盐酸利托君
胶囊
溶出度
紫外分光光度法
ritodrine hydroehloride
capsule
dissolution
UV spectrophotometry