奥沙普秦分散片有关物质方法的研究

Oxaprozin Dispersible Tablets studies of physical methods

目的:确定奥沙普秦分散片有关物质的检查方法,通过有关物质检查方法控制药品的质量。方法:采用HPLC法,以十八烷基硅烷键合硅胶为填充剂;以乙腈-水(用磷酸调pH值为2.5)(50:50)为流动相;检测波长为254nm;流速1.0mL/min;进样量20μL,进行有关物质测定。结果:本品的的理论塔板数按奥沙普秦计算均不低于2000。结论:该方法操作简便,结果准确,可用于奥沙普秦分散片有关物质的检查。

Objective：To determine the method to inspect Oxaprozin Dispersible Tablets related substances, and control drug quality by inspect related substances. Methods ：We used octadecyl silane chemically bonded sili- ca as filler; acetonitrile -- water pH value of 2.5 （with phosphoric acid） （50：50） as mobile phase;gradient elu- tion; flow rate 1.0mL/min; detection wave length 254nm; injection volume 20μL by using HPLC method, and determine relevant materials. Results： The the theoretical plate number of this product calculated by Oxaprozin is not less than 2000. Conclusion：This method is simple, and the result is accurate. It can be used for physical examination of Oxaprozin Dispersible Tablets.