目的建立小儿遗尿分散片中α-细辛醚、β-细辛醚的含量测定方法。方法采用反相高效液相色谱法(RP—HPLC)测定。色谱柱:Hypersil ODS C18柱(4.6×250mm,5μm),流动相为甲醇:水(60:40),检测波长:257nm;柱温:30℃;流速:1.0ml/min。结果α-细辛醚在0.051—1.286mg/ml范围内与峰面积线性关系良好,相关系数为0.9996,平均加样回收率为92.46%,RSD为3.56%。结论所建立的方法简便、准确,可作为小儿遗尿分散片的质量控制方法。
Objective To establish the assay method for quantitative determination of α-asarone and β- asarone in children' s nocturnal enuresis dispersible tablet ( Xiaoer Yiniao dispersible tablet). Methods Reverse-phase HPLC with Hypersil ODS C18 (4. 6 × 250 mm,5 μm)column was applied. The chromatographic conditions were as follow : methanol : water ( 60 : 40 ) as the mobile phase, detection wavelength at 257 nm, column temperature at 30℃ and the flow rate being 1.0 ml/min. Results The liner range of calibration curve was 0. 051 - 1. 286 mg/ml for α-asarone ( r = 0. 9996). The average recovery was92.46% and RSD was 3.56%. Conclusion The method is simple and accurate, and can be used as a quality control method for Xiaoer Yiniao dispersible tablet.