高效液相色谱法测定复方氯唑沙宗胶囊有关物质
Determination of related substances in compound chlorzoxazone capsules by HPLC
王小兵 1徐玉文 1郑静 1冷佳蔚1
作者信息
- 1. 山东省食品药品检验所,济南250101
- 折叠
摘要
目的:建立复方氯唑沙宗胶囊中有关物质的HPLC检测方法.方法:采用Phenomenex Luna(2)C18柱(250mm ×4.6mm,5μm),流动相为甲醇-0.05 mol·L-1的磷酸氢二钠溶液(40:60),检测波长为280 nm,柱温30℃,流速为1.0 mL· min-1.结果:主成分对乙酰氨基酚和氯唑沙宗与各有关物质分离度良好,3种已知杂质对氨基酚、对氯苯酚和2-氨基-4-氯苯酚分别在5.26～15.78,10.72～32.16和20.23 ～60.68 μg·mL-1的浓度范围内有良好的线性关系,平均回收率均在97.4％～99.4％,RSD均在0.45％～0.59％.结论:该方法准确、简便、灵敏度高,可有效控制复方氯唑沙宗胶囊的质量.
Abstract
Objective:To establish a RP-HPLC method for determination of related substances of compound chlorzoxazone capsules.Methods:The separation was performed on a Phenomenex Luna (2)C1s (250 mm × 4.6 mm,5 μm)chromatographic column.The mobile phase was methanol-Na2HPO4 (0.05 mol· L-1,40:60)and flow rate was 1 mL·min-1 UV detective wavelength was set at 280 nm.The column temperature was maintained at 30 ℃.Results:Paracetamol,chlorzoxazone and their related substances were well separated.The calibration curves of three known related substances were linear in the concentration ranges of 5.26 ～15.78,10.72 ～32.16 and 20.23 ～60.68μg·mL-1,respectively.The average recoveries were 97.4％ ～ 99.4％ with RSD of 0.45％ ～ 0.59％.Conclusion:The method is accurate,simple and highly sensitive,and can be used for the quantity control of compound chlorzoxazone capsules.
关键词
高效液相色谱法/氯唑沙宗/对乙酰氨基酚/有关物质/已知杂质Key words
HPLC/chlorzoxazone/paracetamol/related substances/known impurities引用本文复制引用
基金项目
国家药典委员会资助项目(国药典化发[2010]84号)
出版年
2013
NETL
NSTL
维普
万方数据