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PhenomenexLuna(2)C,。柱(250mm×4.6mm,5μm),流动相为甲醇-0.05mol·L-1。的磷酸氢二钠溶液(40:60),检测波长为280nm,柱温30℃,流速为1.0mL·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20.23~60.68μg·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。
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) C18 (250 mm× 4.6 ram, 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 ehlorzoxazone capsules.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2013年第18期2206-2209,2218,共5页
Chinese Journal of New Drugs
基金
国家药典委员会资助项目(国药典化发[2010]84号)