谷维素片溶出度测定方法考察及溶出行为评价

Study on Dissolution Determination Method and Dissolution Behavior of Oryzanol Tablets

目的:建立谷维素片的溶出度方法并对不同厂家样品进行溶出曲线比较。方法:采用HPLC法,使用Polypak NH2色谱柱(250 mm×4.6 mm,5μm),以甲醇-水(90∶10);流速:1.0 ml·min^-1;柱温:35℃;检测波长:325 nm;溶出度试验采用桨法,以0.15%十二烷基二甲基氧化胺溶液900 ml为溶出介质,转速为75 r·min^-1。结果:在本文色谱条件下,谷维素在0.551~22.040μg·ml^-1(r=0.9999)范围内线性关系良好;平均回收率为103.1%,RSD为0.8%(n=9);溶出度方法较好地反映了不同厂家谷维素片溶出行为的差异。结论:建立的HPLC溶出度测定方法简单方便,具有较好的专属性、精密度和准确度,溶出方法能较好地体现不同厂家样品间的差异。

Objective:To establish a method to determine the dissolution of oryzanol tablets and evaluate the dissolution curves of different samples.Methods:An HPLC method was used,and the separation was performed on a Polypak NH2(250 mm×4.6 mm,5μm)column with the mobile phase consisting of methanol-water(90∶10)at a flow rate of 1.0 ml·min^-1.The column temperature was 35℃.The detection wavelength was 325 nm.The paddle method was used for the dissolution test with 900 ml 0.15%N,N-dimethyldodecylamine-N-oxid solution as the medium and the rotation rate was set at 75 r·min^-1.Results:Under the chromatographic conditions in the study,oryzanol revealed a good linear relationship within the range of 0.551-22.040μg·ml^-1(r=0.9999).The average recovery was 103.1%with the RSD of 0.8%(n=9).The dissolution method was suitable,which showed differences in the dissolution among the products from different manufacturers.Conclusion:The established HPLC method is simple,which shows good specificity,precision and accuracy.The dissolution method can reflect differences among products from different manufacturers.