HPLC-RID法测定布洛芬口服溶液中甘油、山梨醇的含量

Content Determination of Glycerin and Sorbitol in Ibuprofen Oral Solution by HPLC-RID

目的:建立高效液相色谱-示差折光检测法(HPLC-RID)测定布洛芬口服溶液中甘油和山梨醇的含量。方法:采用NH 2氨基柱(Waters Spherisorb)(4.6mm×250mm,5.0μm),流动相为乙腈-水(73∶27),流速为1mL/min,进样量为10μL,柱温25℃,RID检测器温度35℃。结果:甘油和山梨醇可有效分离,甘油、山梨醇范围及线性方程分别为25~150μg,Y甘油=74575 X-1262.4(r=0.9999);10~60μg,Y山梨醇=91463 X-41541(r=0.9995);甘油、山梨醇平均回收率分别为99.9%(RSD 0.68%),100.2%(RSD 0.27%)。结论:该方法灵敏、简便、重复性好,可为布洛芬口服溶液中甘油和山梨醇的质量控制提供参考。

Objective:To establish a HPLC-RID method for simultaneously determining the content of Glycerin and Sorbitol in ibuprofen oral solution.Method:The content of Glycerin and Sorbitol was determined by HPLC-RID,chromatographic conditions were as follows:Waters Spherisorb NH 2 column(4.6mm×250mm,5.0μm),the mobile phase of acetonitrile waters acetate(73∶27),column temperature was 25℃,the flow rate was 1.0mL/min and RID temperature was 35℃,the injection volume was 10μL.Result:Glycerin showed a good linear relationship Y glycerin=74575 X-1262.4(r=0.9999)with the range of 25~150μg,Sorbitol showed a good linear relationship Y sorbitol=91463 X-41541(r=0.9995)with the range of 10~60μg,the glycerin average recovery of glycerin was 99.9%with RSD 0.68%,the sorbitol average recovery of sorbitol was 100.2%with RSD 0.27%.Conclusion:This method is sensitive,simple and reproducible,it could provide a reference for determining the content of Glycerin and Sorbitol in Ibuprofen oral solution.