摘要
目的建立萘哌地尔口服固体制剂溶出度测定方法。方法采用浆法,以0.1mol·L-1盐酸溶液为溶出介质,转速为50r·min-1,紫外分光光度法测定溶出量,检测波长279nm。结果萘哌地尔在12.48～37.44μg·mL-1浓度范围内线性关系良好(r=0.9999),高、中、低3个浓度的平均回收率分别为100.62%、99.51%、101.60%,RSD分别为1.01%、1.10%、0.72%。结论所建立方法可用于萘哌地尔制剂质量控制。
Objective To establish a method for the dissolution determination of naftopidil oral solid preparation. Methods The paddle method was adopted. Using 0.1tool oL-1 hydrochloric acid as the solvent, the rotation speed at 50 r·min^-1 ,UV method was used to determine the content of naftopidil. The detection wave length was at 279nm. Results The assay displayed a good linearity over the concentration range of 12.48-37.44ug . mL^-1 （r = 0. 9999）, the average recovery respectively was 100. 62%, 99.51%, 101.60% and the RSD was 1.01%, 1.10%, 0.72%. Conclusions The establish criteria are suitable for the quality control of Naftopidil preparation.
出处
《齐齐哈尔医学院学报》
2012年第15期1994-1995,共2页
Journal of Qiqihar Medical University
基金
国家药典委员会药品标准提高研究课题(972-4)
