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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 the optimal dissolution of levonorgestrel tablets. Methods: The third method of two dissolution assays of Chinese Pharmacopoeia (2005 edition) was adopted, and 200ml of 0.5% sodium dodecyl sulfate (SDS) solution was used as the dissolution medium. The rotation speed was 75r · min ~ (-1) For 45min, using high performance liquid chromatography detection of dissolution. RESULTS: Levonorgestrel had a good linearity (r = 1.000 0) in the range of 0.01499-0.2998 μg with an average recovery of 98.3% and RSD of 1.0% (n = 18). Conclusion: This method conforms to the principle of dissolution method, which can control the intrinsic quality of levonorgestrel tablets.