复方盐酸吡格列酮二甲双胍缓释片中盐酸吡格列酮溶出度的测定

目的 开发简单、快速、灵敏度高的复方盐酸吡格列酮/盐酸二甲双胍缓释片中盐酸吡格列酮溶出度的测定方法.方法使用HPLC法,以甲醇∶0.025 mol·L-1乙酸铵水溶液(65:35)为流动相;流速1.0 ml·min-1;检测波长229 nm.结果盐酸吡格列酮在0.5～20.2 mg·L-1范围内线性关系良好(r=0.9...

Dissolution determination of pioglitazone hydrochloride in pioglitazonehydrochloride and metformin hydrochloride sustained-released compound tablets

Aim To develop a simple,rapid,and sensitive dissolution determination method of pioglitazone hydrochloride in pioglitazone hydrochloride and metformin hydrochloride sustained-released compound tablets.Methods A high performance liquid chromatographic method was developed with a mobile phase containing a mixture of methanol and ammonium acetate solution（0.025 mol·L-1）in the ratio of 65∶35.The flow rate was 1 ml·min-1 and effluents were monitored at 229 nm.Results The linear correlation was good for pioglitazone hydrochloride in the range of 0.5~20.2 mg·L-1（r=0.999 9）.Sample solutions were stable in 8 hours.RSD for accuracy was 0.92%,and the median coefficient of recovery was 100.2%.Conclusion The method is simple,accurate and reproducible.