高效液相色谱法和电位滴定法测定布洛芬钠原料药含量  

Determination of ibuprofen sodium by HPLC and potentiometry titration

作　　者：洪桑桑 王海翔[1] 王岁楼[1] 

机构地区：[1]中国药科大学,江苏南京211198

出　　处：《药学研究》2016年第11期642-645,共4页Journal of Pharmaceutical Research

基　　金：中央高校基本科研业务费(No.3010010152)

摘　　要：摘要：目的分别建立电位滴定法和高效液相色谱法测定布洛芬钠原料药含量。方法高效液相色谱法采用UltimateAQC18色谱柱（4．6mmx250mm，5μm），流动相为0．05％磷酸水-乙腈（60：40，V／V），流速2．0mL·min-1，检测波长214nm，柱温30℃。电位滴定法以无水乙醇为溶剂，用盐酸标准溶液（0．1mol·L-1）滴定，电位法判定滴定终点。结果高效液相色谱法：在0．08—0．32mg·mL-1。范围内线性关系良好，r=0．9998；方法精密度RSD为0．41％（n=6）；平均回收率为99．4％（n=9），RSD为0．90％。电位滴定法：在0．18—0．42g范围内线性关系良好，r=1．0000；方法精密度RSD为0．14％（m=6）；平均回收率为100．2％（n=9），RSD为0．13％。结论电位滴定法和高效液相色谱法的含量测定结果无显著性差异，均可用于布洛芬钠原料药含量测定。Objective To establish a potentiometry titration method and an HPLC method for the determination of ibu-profen sodium.Methods The HPLC method was performed on a Cls column 14.6 mmx250 mm ,5 μm with mobile phaseof 0.05% phosphate acid-aeetonitrile （60：40,V/VI at flow rate of 2.0 mL · min-1 .The UV detection was set at 214 nmand the colum temperature was matained at 30 ℃. Ethanol was used as solvent for potentiometry titration. The samplesolution was titrated with 0.1 mol · L-1 hydrochloric acid solution.The end point was decided by potentiometric method.Re-sults HPLC：the liner range for ibuprofen sodium was 0.08-0.32mg·mL-1（r = 0.999 8） , the precision RSD was 0.41%（n = 6 ） , the average recovery was 99.4% with an RSD of 0.90% （ n = 9 ）. Potentiometry titration ： the liner range foribuprofen sodium was 0.18-0.42 g （r= 1.000 0） ,the precision RSD was 0.14% （n=6） ,the average recovery was 100.2%with an RSD of 0. 13% （ n = 9 ）.Conclusion There was no significant difference between the results of potentiometry titra-tion method and HPLC method and indicated that two methods both could be used to determine the content of ibuprofen so-dium substances.

关 键 词：高效液相色谱法 电位滴定法 布洛芬钠 含量测定 

分 类 号：R927.2[医药卫生—药学]