摘要
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.
作者
张丽
李勇
王昆
张伟
Zhang Li;Li Yong;Wang Kun;Zhang Wei(School of Pharmaceutical Science&Yunnan Key Laboratory of Pharmacology for Natural Products,Kunming Medical University,Kunming 650500,China;Kunming Longjin Pharmaceutical Co.,Ltd.,Kunming 650503,China)
出处
《云南化工》
CAS
2022年第8期52-55,共4页
Yunnan Chemical Technology
基金
云南省科技厅2021年科技计划(202102AA310024)。
关键词
UV法
HPLC法
替格瑞洛分散片
含量均匀度
ultraviolet spectrophotometry
high performance liquid chromatography
ticagrelor dispersible tablets
content uniformity