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目的建立利肝隆片中五味子醇甲含量的HPLC测定法。方法采用SUPELCO Discovery C18柱,以甲醇-水(13∶7)为流动相,检测波长定为250 nm,柱温35℃,流速1.0 mL/min。在此色谱条件下,进行HPLC法测定利肝隆片中的五味子醇甲的方法学考察和样品含量测定。结果五味子醇甲(0.202～3.03)μg范围内,峰面积与浓度呈良好的线性关系(r=0.9991),回收率均值为98.21%(RSD为1.65%)。稳定性、精密度和重复性试验均符合要求。4批样品中五味子醇甲的含量在(0.436～0.520)mg/片范围内,因考虑到药材来源、制剂生产和贮藏等因素,故暂订本品每片含五味子按五味子醇甲(C24H32O7)计,不得少于0.40 mg。结论按上述条件,采用HPLC法测定利肝隆片中的五味子醇甲的含量,方法简便、专属强,能较好的控制利肝隆片质量。
OBJECTIVE To establish an HPLC assay for the content of schisandrin in Li Liverong Tablets. Methods The SUPELCO Discovery C18 column was used. The mobile phase was methanol - water (13: 7). The detection wavelength was set at 250 nm. The column temperature was 35 ℃ and the flow rate was 1.0 mL / min. Under this chromatographic conditions, the methodological determination and the determination of the content of schisandrin A in lilfeolol tablets were carried out by HPLC. Results There was a good linear relationship between peak area and concentration in the range of 0.202 ~ 3.03 μg (r = 0.9991). The average recovery was 98.21% (RSD 1.65%). Stability, precision and repeatability test are in line with the requirements. The content of schisandrin in four batches of samples was in the range of (0.436-0.520) mg / tablet. Considering the origin of medicinal materials, the production and storage of preparations and other factors, the content of schisandrins (C24H32O7) Not less than 0.40 mg Conclusion According to the above conditions, HPLC method was used to determine the content of schisandrin A in Lilongtong tablet. The method was simple, specific and strong, and could better control the quality of.