顶空气相色谱法测定布洛芬缓释片中乙醇残留量

Determination of Residual Ethanol in Ibuprofen Sustained Release Tablets by Headspace Gas Chromatography

目的:建立顶空气相色谱法测定布洛芬缓释片中乙醇残留量。方法:采用Agilent HP-FFAP(30 m×0.320 m,0.25μm)毛细管柱为色谱柱,柱温为40℃,进样口温度为150℃,FID检测器温度为250℃,顶空瓶平衡温度为85℃,平衡时间为3 0分钟,进样量1 mL,载气为氮气,流速2.0 mL·min-1。结果:乙醇在0.05036～2.0144mg·mL-1范围内呈良好线性关系(r=0.9997,n=6),平均回收率(n=9)为100.9%(RSD为0.24%)。结论:本法简便、准确,重复性好,专属性强,灵敏度高,可用于布洛芬缓释片中乙醇残留量的测定。

Objective:To determine the residual ethanol in Ibuprofen Sustained Release Tablets by Headspace Gas Chromatography.Methods: Agilent HP-FFAP(30 m×0.320 m,0.25 μm) was used.The column temperature was 40 ℃.The injection port temperature was 150 ℃.The FID detector temperature was 250 ℃.The equilibrium temperature of the headspace gas bottle was 85 ℃.The equilibrium time was 30 minutes.The injection volume was 1 mL.The Carrier gas was nitrogen.The flow rate was 1.0 mL·min-1.Results:A good linear correlation of ethanol was observed within the range of 0.05036～2.0144 mg·mL-1(r=0.9997,n=6).The average recovery was 100.9% with RSD 0.24%(n = 9).Conclusion:The method is simple,accurate and repeatable,with strong selectivity and high sensitivity.It can be applied to the determination of of residual ethanol in ibuprofen sustained release capsule.