摘要
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-tersXTerraMSC18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.
出处
《中国药房》
CAS
CSCD
2012年第24期2286-2288,共3页
China Pharmacy