赛立替尼胶囊溶出度方法的考查

Investigation on Dissolution Assay Method of Ceritinib Capsules

目的:建立赛立替尼胶囊的溶出度测定方法,并考查其质量。方法:按照《中国药典》2015版四部通则0931溶出度与释放度测定法第二法,分别对不同溶出介质、转速等条件进行比较,选择合适的溶出条件,采用HPLC法检测并计算溶出结果。结果:本测定方法在0.1~0.3mg·mL^(-1)浓度范围内呈良好的线性关系;回收率、精密度均符合2015版《中国药典》规定。建立了以0.01mol·L^(-1) HCl 900m L为溶出介质,桨法,使用沉降篮,转速60r·min^(-1)作为赛立替尼胶囊的溶出方法,该方法稳定性良好。结论:本实验所建立的赛立替尼胶囊溶出度方法可行,能够客观地反映胶囊的溶出情况,从而控制胶囊质量。

Objective： To establish a dissolution assay method of Ceritinib Capsules for determining its quality. Methods： According to the apparatus Ⅱ of the dissolution and release rate test in the fourth part of Chinese Pharmacopoeia （2015 edition）. Different releasing medium and rotational speed was respectively studied to acquire appropriate condition, the dissolution rate was analyzed and calculated by HPLC. Results：The HPLC method was shown to be accurate, precise anti it had good linearity in the concentration range of 0.1 -0.3mg·mL^-1. The dissolution method was established with paddle method. Dissolution medium was 0.01 mol·L-1 HCl 900mL. Rotational speed was 60r·min^-1. This method was well in stability. Conclusion：This method is sensitive, accurate and reliable, and it could be aoolied to determine the dissolution of Ceritinib Capsules.