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目的建立测定柳酚咖敏片中3组分的溶出度测定方法。方法采用Inertsil ODS 3 C18色谱柱(250 mm×4.6 mm,5μm),以甲醇-体积分数0.35%三乙胺溶液(磷酸调节pH值至3.0)为流动相,梯度洗脱,流速为1.0 mL.min-1,检测波长275 nm,柱温40℃。结果对乙酰氨基酚、咖啡因、水杨酰胺质量浓度分别在36.10216.6、4.5627.38和35.54213.24 mg.L-1内与峰面积呈良好线性关系(r=0.999 9,n=5),平均回收率(n=9)分别为100.1%(RSD=1.1%)、100.2%(RSD=0.7%)和99.8%(RSD=1.5%)。结论该方法简单、准确,可用于柳酚咖敏片中3组分的溶出度测定。
Objective To establish a method for the determination of the dissolution of three components in the Liushen Tea Tablet. Methods The column was eluted with a gradient of Inertsil ODS 3 C18 (250 mm × 4.6 mm, 5 μm) using a mobile phase of methanol-0.35% triethylamine (adjusted to pH 3.0 with phosphoric acid) at a flow rate of 1.0 mL. min-1, detection wavelength 275 nm, column temperature 40 ℃. Results There was a good linear relationship between the concentration of paracetamol, caffeine and salicylamide in the area of 36.10216.6, 4.5627.38 and 35.54213.24 mg.L-1, respectively (r = 0.999 9, n = 5) The average recoveries (n = 9) were 100.1% (RSD = 1.1%), 100.2% (RSD = 0.7%) and 99.8% (RSD = 1.5%), respectively. Conclusion The method is simple and accurate and can be used for the determination of the dissolution of three components in the Liupansan Tablets.