HPLC法测定复方磷酸可待因糖浆主成分含量的研究  

Study on Determination of Major Components of Compound Codeine Phosphate Syrup by HPLC

作　　者：刘心[1] 余仲平[1] 杨宏伟[2] 易大为[2] 

机构地区：[1]东北制药集团沈阳第一制药有限公司,沈阳110027 [2]辽宁省食品药品检验所,沈阳110023

出　　处：《中国药品标准》2013年第2期119-121,共3页Drug Standards of China

摘　　要：目的:建立测定复方磷酸可待因糖浆中磷酸可待因和盐酸异丙嗪的高效液相色谱方法。方法:采用氰基键合硅烷色谱柱为固定相,流动相为0.01 mol.L-1己烷磺酸钠溶液-乙腈-甲醇(54∶23∶23),流量1.0 mL.min-1,检测波长284 nm。结果:磷酸可待因的线性范围为0.3～2.8μg(r=0.9999),平均回收率为100.8%,定量限和检测限分别为10 ng和3 ng;盐酸异丙嗪的线性范围为0.2～1.9μg(r=0.9998),平均回收率为100.3%,定量限和检测限分别为6 ng和2 ng。结论:该方法简单、可靠,适用性好,可用于复方磷酸可待因糖浆的质量控制。Objective： To establish a HPLC method for determination of codeine phosphate and promethazine hydrechloride in Compound Codeine Phosphate Syrup. Method： CN column was used as stationary phase, the mobile phase was consisted of 0. 01 tool · L-1 sodium hexanesulfonate solution-acetonitrile-methanol （54： 23：23 ） at the flow rate of 1.0ml · min -1, and the detection wavelength was 284 nrrL Result： As for codeine phosphate, the linear range was 0. 3-2. 8 μg（r =0. 9999）, and the average recovery was 100. 8%, the limit of quantification was 10 ng, and limit of detection was 3 ng; as for promethazine hydrochloride, the linear range was 0. 2-1.9μg （r = 0. 9998）, and the average recovery was 100. 3%, the limit of quantification was 6 ng, and the limit of detection was 2 n~ Conclusion：The method is simple, reproducible and suitable, it can be used for the quality control of Codeine Phosphate Compound Syrup.

关 键 词：复方磷酸可待因糖浆 磷酸可待因 盐酸异丙嗪 含量测定 

分 类 号：R921.2[医药卫生—药学]