雷诺嗪缓释片体外释放度的测定

In vitro dissolution of ranolazine sustained-release tablets

目的建立雷诺嗪缓释片的体外释放度测定方法。方法以0.9%的盐酸水溶液为溶出介质,溶出方法为转篮法(100 r.min-1)。结果采用紫外分光光度法在272 nm测定雷诺嗪的浓度,其检测线性范围为10～200 mg.L-1(r=0.999 9),平均回收率为98.04%(RSD=1.26%);3批样品在2、6、12 h的释放量分别为标示量的30%、60%、70%以上。结论该方法准确、可靠,可用于该制剂的释放度测定。

Aim To establish a method for the determination of the dissolution of ranolazine sustained-release tablets.Methods Ranolazine sustained-release tablet was dissolved in 0.9 % HCL medium with stirring basket method at 100 r· min-1.Results Calibrations between 10～200 mg· L-1 exhibited consistent linearity and reproducibility（r=0.999 9）.The wavelength was 272 nm,and the average recovery rate was 98.04 %（RSD = 1.26 %）.3 batch of samples approved the dissolutions of 2,6,12 h were all above 30%,60%,70%,respectively.Conclusion This method is accurate,reliable and can be used for the preparation of the dissolution of ranolazine sustained-release tablet.