罗格列酮钠肠溶片的制备及质量控制

Preparation and Quality Control of Rosiglitazone Sodium Enteric-coated Tablets

目的:制备罗格列酮钠肠溶片并建立其质量控制方法。方法:以罗格列酮钠为主药制备制剂,采用高效液相色谱法测定其中主药的含量。结果:所制制剂为白色包衣片,检查符合2005年版《中国药典》中的相关规定;罗格列酮检测浓度的线性范围为10～83μg·mL^(-1)(r=0.999 9),平均回收率为99.64%(RSD=1.05%)。结论:该制剂制备工艺可行,质量可控。

RESULTS： OBJECTIVE： To prepare rosiglitazone sodium enteric- coated tablets and establish its quality control method The tablets were prepared with rosiglitazone sodium and the content of rosiglitazone was determined by HPLC. The preparation was white coated tablets with its property up to the standard stated in Chinese Pharmacopeia （2005 Edition） . The linear range of rosigtitazone was 10-83μg · mL ^-1 （r = 0.999 9） and its average recovery was 99.64% （RSD = 1.05% ） . CONCLUSION： The preparation process was proved to be feasible and the quality of the preparation was controllable.