HPLC法测定卡左双多巴缓释片中的有关物质
Determination of the Related Substances in Carbidopa and Levodopa Sustained-release Tablets by HPLC
时晓燕 1庞余江 2朱志祥 2潘增玉 3张丽萍 3冯中1
作者信息
- 1. 中国海洋大学医药学院,山东青岛 266003;鲁南制药集团股份有限公司,山东省药物国际化工程实验室,山东临沂 273400
- 2. 中国海洋大学医药学院,山东青岛 266003
- 3. 鲁南制药集团股份有限公司,山东省药物国际化工程实验室,山东临沂 273400
- 折叠
摘要
建立了 HPLC法测定卡左双多巴(左旋多巴-卡比多巴)缓释片中的有关物质.采用Waters X-Bridge C18柱(4.6 mm×250 mm,5 μm),以pH 1.8的磷酸盐缓冲液为流动相A、pH 1.8的磷酸盐缓冲液和甲醇(体积比250∶750)为流动相B,梯度洗脱.流速为1.0 mL/min,检测波长为280 nm,柱温为25 ℃,进样量为20 μL.结果显示,主峰及各杂质峰均能良好分离,卡比多巴、左旋多巴和7个有关物质的线性关系良好,7个有关物质的平均回收率(n=9)分别为98.97％、100.79％、102.69％、98.13％、102.34％、95.97％、100.80％.强制性降解试验结果显示,该方法可指示各条件下的降解产物.相较于美国药典收录的有关物质检测方法,该方法专属性高、简便耐用,可用于卡左双多巴缓释片的生产控制及稳定性样品测定.
Abstract
An HPLC method was established for the determination of the related substances in carbidopa and levodopa sustained-release tablets.The Waters X-Bridge C18 column(4.6 mm×250 mm,5 μm)was used,and the analysis was carried out in the gradient elution mode with pH 1.8 phosphate buffer solution as mobile phase A,and pH 1.8 phosphate buffer solution-methanol(250∶750)as mobile phase B.The flow rate was 1.0 mL/min,the detection wavelength was 280 nm,the column temperature was 25 ℃,and the injection volume was 20 μL.The results showed that the main peaks and related substance peaks could be well separated,and it was linear for carbidopa,levodopa,and the seven related substances.The average recoveries(n=9)of seven related substances were 98.97％,100.79％,102.69％,98.13％,102.34％,95.97％,and 100.80％,respectively.The results of the forced degradation tests showed that this method could indicate the degradation products under various conditions.This method has higher specificity,simplicity,and durability than the methods included in the USP 43.It can be used for the production control and stability sample determination of carbidopa and levodopa sustained release tablet.
关键词
卡左双多巴缓释片/卡比多巴/左旋多巴/高效液相色谱/有关物质/强制性降解Key words
carbidopa and levodopa sustained-release tablet/carbidopa/levodopa/HPLC/related substance/forced degradation引用本文复制引用
基金项目
山东省重大科技创新工程项目(2020CXGC010506)
出版年
2024
NETL
NSTL
万方数据