HPLC法同时测定布洛芬口服液体制剂中布洛芬、苯甲酸钠的含量

Simultaneous Content Determination of Ibuprofen and Sodium Benzoate in Ibuprofen Oral Solution by HPLC

目的:建立同时测定布洛芬口服液体制剂中布洛芬、苯甲酸钠含量的方法。方法:采用高效液相色谱法。色谱柱为Wa-tersXTerraMSC18柱,流动相为乙腈-0.5%十二烷基磺酸钠-磷酸(V/V/V)=520:480:1,检测波长为230nm,流速为1mL.min-1,进样量为10μL,柱温为30℃。结果:布洛芬和苯甲酸钠检测浓度分别在154.7～1829.0mg.L-1(r=0.9998)、41.24～288.6mg.L-1(r=0.9996)范围内与其峰面积积分值呈良好的线性关系,平均加样回收率分别为99.40%、100.01%、100.54%,98.97%、99.03%、100.61%,RSD分别为0.10%、0.28%、0.12%,0.17%、0.12%、0.18%(n=9)。结论:本方法简便、快速、专属性强,可用于布洛芬口服液体制剂的质量控制。

OBJECTIVE： To establish the method for the content determination of ibuprofen and sodium benzoate in Ibuprofen oral solution. METHODS： HPLC method was adopted. The determination was performed on waters XTerra MS C,8 column with mobile phase consisted of acetonitrile-0.5% sodium dodecyl sulfate-phosphoric acid （V/V/V） was 520：480：1 at the flow rate of 1 mL-min^-1. The detection wavelength was set at 230 nm and injection volume was 10 txL. The column temperature was 30 %. RESULTS： The linear range of ibuprofen and sodium benzoate were 154.7-1 829.0 mg.L^-1（r=0.999 8） and 41.24-288.6 mg.L （r=0.999 6）, respectively. The average recoveries were 99.40%, 100.01%, 100.54%, 98.97% ,99.03%, 100.61% （RSD=0.10%, 0.28% ,0.12%, 0.17% ,0.12% ,0.18% （n=9））. CONCLUSION： The method is simple, rapid and specific, and it can be used for the content control of ibuprofen and sodium benzoate in oral solution effectively.