中国药业2024，Vol.33Issue(2)：71-74,4.DOI:10.3969/j.issn.1006-4931.2024.02.017
高效液相色谱-电雾式检测器法测定托吡酯片中主要成分及杂质含量
Determination of Main Component and Impurities in Topiramate Tablets by HPLC-CAD
黄小琴 1季大伟 1仇雅静 1孙枫涛2
作者信息
- 1. 江苏省泰州市药品检验院,江苏 泰州 225300
- 2. 江苏省泰州市中医院,江苏 泰州 225300
- 折叠
摘要
Abstract
Objective To establish a high-performance liquid chromatography-charged aerosol detection(HPLC-CAD)method for the determination of main component and impurities in Topiramate Tablets.Methods The chromatographic column was Waters SunFire C18 column(150 mm×4.6 mm,5 μm),the mobile phase was acetonitrile-0.2%formic acid aqueous solution(35∶65,V/V),the flow rate was 1.0 mL/min,the column temperature was 35℃,the atomization temperature was 35℃,the filtration constant was 3.6 s,the power function value was 1.0,the collection frequency was 10 Hz,and the injection volume was 10 μL.Results The linear range of topiramate was 0.05-1.0 mg/mL(r = 0.995 6).The limit of detection and limit of quantification were 1 μg/mL and 3 μg/mL,respectively.The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rate of topiramate was 100.19%with an RSD of 1.19%(n = 9).The contents of topiramate and total impurities in three batches of samples were in the range of 97.98%to 98.96%and 0.25%to 0.31%respectively.Conclusion The established method is simple,accurate and reliable,which can be used for the content determination of main component and impurities in Topiramate Tablets.关键词
高效液相色谱-电雾式检测器法/托吡酯/杂质/含量测定/质量控制Key words
high-performance liquid chromatography-charged aerosol detection/topiramate/impurity/content determination/quality control分类
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黄小琴,季大伟,仇雅静,孙枫涛..高效液相色谱-电雾式检测器法测定托吡酯片中主要成分及杂质含量[J].中国药业,2024,33(2):71-74,4.
