左炔诺孕酮片溶出度测定方法考察

Study on Dissolution Test for Levonorgestrel Tablets

目的:建立左炔诺孕酮片的最佳溶出度方法。方法:采用《中国药典》2005年版二部溶出度测定法第三法,以0.5%十二烷基硫酸钠(SDS)溶液200ml为溶出介质,转速为75r·min^(-1),取样时间为45min,采用高效液相色谱法检测溶出量。结果:左炔诺孕酮在0.01499～0.2998μg范围内线性关系良好(r=1.000 0);平均回收率为98.3%,RSD为1.0%(n=18)。结论:本方法符合溶出度方法的建立原则,可控制左炔诺孕酮片的内在质量。

Objective ： To establish a method for testing the dissolution of levonorgestrel tablets. Method： The Apparatus Ⅲof dissolution test method of ChP 2005 edition volII was used, dissolution medium was 0.5% sodium laurylsulfate. Rev was 75r·min^-1. After 45 min the dissolution solution was taken and analyzed by HPLC method. Result： The linear relationship was in the range of 0. 01499 - 0. 2998μg（ r = 1. 000 0）. The mean recovery of levonorgestrel was 98.3%, with RSD 1.0% （ n = 18 ）. Conclusion ： The method is accorded with the dissolution test principle. It can control the internal quality of levonorgestrel tablets.