UV法测定替格瑞洛分散片的含量均匀度

Determination of Content Uniformity of Ticagrelor Dispersible Tablets by UV Method

建立了UV法测定替格瑞洛分散片的含量均匀度。采用UV法对替格瑞洛分散片的含量均匀度进行了测定,以乙腈-水(体积比35∶65)为溶剂,检测波长为300 nm,检测质量浓度为15μg/mL。替格瑞洛质量浓度在3.0~25.0μg/mL范围内与吸光度线性关系良好(r=0.9999,n=8),样品在12 h内稳定,平均回收率为101.75%,RSD为0.92%(n=12);采用UV法测得3批样品的A+2.2S分别为5.04、1.57和3.92,含量均匀度均在合格范围内,A+2.2S≤15.0,且与HPLC法测定结果相比无明显差异。所建立的方法准确度高、快速、简便、经济、重现性好,可用于替格瑞洛分散片含量均匀度的测定。

To establish a UV method to determine the content uniformity of ticagrelor dispersible tablets.The content uniformity of ticagrelor dispersible tablets was determined by UV spectrophotometry method.Acetonitrile-water(35∶65,V/V)was used as the solvent,the detection wavelength was 300 nm,and the detection concentration was 15μg/mL.The mass concentration of ticagrelor has a good linear relationship with absorbance in the range of 3.0~25.0μg/mL(r=0.9999,n=8),and the sample was stable within 12 h.The average recovery rate was 101.75%,with a RSD of 0.92%(n=12).The A+2.2S of 3 batches of samples measured by UV method are 5.04,1.57 and 3.92 respectively.And the content uniformity is within the qualified range,A+2.2S≤150.There is no significant difference compared with the HPLC method.The established method is highly accurate,fast,simple,economical,and reproducible.It can be used for the determination of ticagrelor dispersible tablets content uniformity.