高效液相色谱法测定胃乐舒颗粒中延胡索乙素的含量

High-performance liguid chromatography for determining tetrahydropalmatione content in Weileshu Granules

目的胃乐舒颗粒现行质量标准采用薄层色谱法鉴别。建立胃乐舒颗粒中延胡索乙素含量的测定方法,可为提高该制剂的质量标准提供研究依据。方法采用高效液相色谱(high-performance liguid chro-matog-raphy,HPLC)法,流动相:乙腈-0.1%磷酸(用三乙胺调pH至6.0)(38∶62);色谱柱:汉邦ODS-C18柱(250 mm×4.6 mm,5μm);体积流量:1.0ml/min;柱温:室温;检测波长:226 nm;进样量:10μl。结果延胡索乙素在6.13～98μg/ml范围内线性关系良好,平均回收率为100.18%,相对标准偏差(relative standard deviation,RSD)为1.5%。结论该方法简便、可靠,可用于胃乐舒颗粒的质量控制。

Objective The quality of Weileshu Granules is normally indentified by thin-layer chromatography（TLC）.The purpose of this study was to establish a method for determining the content of tetrahydropalmatione in Weileshu Granules,and to provide evidence for researches on the quality standard of the preparation.Methods We determined the content of tetrahydropalmatione in Weileshu Granules by high-performance liquid chromatography（HPLC）,with a mobile phase of acetonitrile-0.1% phosphoric acid solution（pH adjusted to 6.0 with triethylamine）（38∶[KG-＊3/5]62）,a chromatographic column of Hanban ODS-C18（250 mm × 4.6 mm,5 μm）,a flow rate of 1.0 ml/min,a column temperature of 35℃,a detection wavelength of 226 nm,and a sample loop volume of 10 μl.Results The calibration curve of tetrahydropalmatione was linear within the range of 6.13-98.00 μg/ml,with a mean recovery of 100.18%（RSD=1.5%）.Conclusion High-performance liguid chromatography is simple,reliable,and applicable to the quality control of Weileshu Granules.