培哚普利片的溶出度研究

目的: 建立培哚普利片的溶出测定方法。 方法: 采用桨法(加沉降篮),0.01 mol·L^-1 盐酸为溶出介质,转速50 r·min^-1,15 min 取样,采用高效液相色谱法测定培哚普利叔丁胺盐的溶出量。 结果: 在1.13~45.00 μg·mL^-1浓度范围内呈良好的线性关系(r=0.9999),平均回收率为100.5%。3批样品在15 min 时的溶出度均超过标示量的85%。3批样品的溶出参数(T₅₀,T_d,m)经单因素方差分析,无明显差异(P>0.05)。 结论: 本方法快速准确,适合测定培哚普利片的溶出度测定。

Objective: To establish a method of the dissolution determination of perindopril tablets. Method: paddle (sinker) method was adopted.Using 0.01 mol·L^-1 hydrochloric acid as the solvent,the rotation speed at 50 r·min^-1,RP-HPLC method was used to determine the content of perindopril tert-butylamine salt. Result: The assay displayed a good linearity over the concentration range of 1.13-45.00 μg·mL^-1 (r=0.9999),the average recovery was 100.5%.the dissolution parameters of three batchs (T₅₀、T_d、m)were analysed using one-way analysis of variance,and the data had no significant different (P>0.05). Conclusion: The method is rapid and accurate,It can be applied to determine dissolution of perindopril tablets.