HPLC法测定酮洛芬缓释胶囊中主药的含量

Determination of the Content of Ketoprofen in Ketoprofen Sustained Release Capsules by HPLC

目的:建立以高效液相色谱法测定酮洛芬缓释胶囊中主药含量的方法。方法:色谱柱为C18,流动相为0.05mol·L-1磷酸二氢钾溶液-甲醇(60∶40),流速为1.0mL·min-1,检测波长为255nm,进样量为20μL。结果:酮洛芬检测浓度的线性范围为10.84～54.20μg·mL-1(r=0.9995);平均回收率为99.91%,精密度为0.26%。结论:本方法操作简便、快速、准确、专属性强,可用于该制剂的含量测定。

OBJECTIVE ： To establish a HPLC method for the determination of ketoprofen in ketoprofen sustained release capsules. METHODS： The determination was performed on C18 column. The mobile phase consisted of 0.05mol· L^-1 KDP solution-methanol （60 ： 40） with a flow rate of 1.0mL · min ^-1. The detection wavelength was set at 255 nm and the sample size was 20μL. RESULTS： The linear range of ketoprofen was 10.84-54.20μg · mL^-1 （r = 0.999 5） with average recovery at 99.91% and precision at 0.26%. CONCLUSION： The determination method is simple, rapid, accurate and specific, and it can be used for the content determination of ketoprofen in ketoprofen sustained release capsules.