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

作　　者：王小兵[1] 徐玉文[1] 郑静[1] 冷佳蔚[1] 

机构地区：[1]山东省食品药品检验所,济南250101

出　　处：《中国新药杂志》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)

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.

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 

分 类 号：R943.3[医药卫生—药剂学] R971[医药卫生—药学]