缬沙坦片的溶出方法学研究

Dissolution curve methodology validation of Valsartan Tablets

目的建立缬沙坦片溶出度的测定方法。方法以磷酸盐缓冲液(pH值6.8)1 000 mL为溶出介质,转速为50 r·min-1,经30 min时取样,采用紫外-可见分光光度法在250 nm处测定吸光度,按外标法计算缬沙坦片的溶出度。通过耐用性、滤膜吸附实验、线性与范围、溶液稳定性、精密度试验、重复性试验、回收率试验等试验研究,对缬沙坦片的溶出方法进行验证。结果该溶出方法学验证结果良好。缬沙坦溶液质量浓度在1.61~17.71mg·L-1内线性关系良好,回归方程为Y=3.17×10-2x-0.6×10-3,r=0.9999;方法的回收率、精密度、重复性符合要求,供试溶液在12 h内稳定。结论本方法能准确测定缬沙坦片的溶出度,控制缬沙坦片的质量。

Objective To establish a measuring method of the dissolution curve of valsartan tablets.Method Dissolution conditions:in the ph6.8 phosphate buffer solution,with the Slurry method of 50 r·min-1 and the dissolution sampling time of 30 min.Through the experimental study of linear and scope,solution stability,precision test,repeatability,recovery test,etc.,the dissolution method of valsartan tablets was validated.Results The results of the dissolution verification methodology were good.There was a good linear relationship when the valsartan tablets concentration was in the range from 1.61 to 17.71 mg·L-1.Linear equation was:Y=3.17×10-2 x–0.6×10-3.The test solution was basically stable in 12 hours.Conclusion The method can accurately determine the dissolution of valsartan tablets.