高效液相色谱法和电位滴定法测定布洛芬钠原料药含量

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Ultimate AQ C18色谱柱（4.6 mm×250 mm，5μm），流动相为0.05％磷酸水-乙腈（60：40，V/ V），流速2.0 mL·min-1，检测波长214 nm，柱温30℃。电位滴定法以无水乙醇为溶剂，用盐酸标准溶液（0.1 mol·L-1）滴定，电位法判定滴定终点。结果高效液相色谱法：在0.08~0.32 mg·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0.18~0.42 g 范围内线性关系良好，r =1.0000；方法精密度 RSD 为0.14％（n=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。

Determination of ibuprofen sodium by HPLC and potentiometry titration

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 C18 column(4.6 mm×250 mm,5 μm)with mobile phase of 0.05% phosphate acid-acetonitrile(60: 40,V/ V)at flow rate of 2.0 mL·min-1 .The UV detection was set at 214 nm and the colum temperature was matained at 30 ℃ . Ethanol was used as solvent for potentiometry titration. The sample solution 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 0.08~0.32 mg·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 for ibuprofen 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.