盐酸吡格列酮片溶出度测定方法的研究

Study on the Dissolution of Pioglitazone Hydrochloride Tablets

目的:建立盐酸吡格列酮片溶出度测定方法。方法:以0.1mol/L 盐酸为溶剂,采用桨法,转速为50r/min,温度(37±0.5)℃,进行累积溶出百分率测定,用 HPLC 法测溶出量。结果:该方法线性关系良好,回归方程为 A=38.49C+133.94,r=0.9995(n=6),平均回收率为99.70%,RSD 为0.44%。结论:测定方法准确,可用于质量控制。

OBJECTIVE:To establish the standard of pioglitazone hydrochloride tablets on its dissolution.METHOD:The accumulation percentage of pioglitazone hydrochloride tablets was measured by HPLC at 229nm in 0.1mol/L HCL solution.The rotational speed was 50r/min,and the temperature was (37±0.5)℃.RESULTS:The calibation was linear,A=38.49C+133.94(r =0.9995,n=6).The average recovery was 99.70%,RSD=0.44%(n=6).CONCLUSION:The method is sensitive and accurate.